Major Recommendations
Note from the National Guideline Clearinghouse (NGC) and the Institute for Clinical Systems Improvement (ICSI): For a description of what has changed since the previous version of this guidance, refer to Summary of Changes Report -- May 2012  . In addition, ICSI has made a decision to transition to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. This document is in transition to the GRADE methodology.
Transition steps incorporating GRADE methodology for this document include the following:
- Priority placed upon available systematic reviews in literature searches.
- All existing Class A (randomized controlled trials [RCTs]) studies have been considered as high quality evidence unless specified differently by a work group member.
- All existing Class B, C and D studies have been considered as low quality evidence unless specified differently by a work group member.
- All existing Class M and R studies are identified by study design versus assigning a quality of evidence. (Refer to Crosswalk between ICSI Evidence Grading System and GRADE below in the "Definitions" section.)
- All new literature considered by the work group for this revision has been assessed using GRADE methodology.
The recommendations for the diagnosis and treatment of major depression in adults are presented in the form of an algorithm with 13 components, accompanied by detailed annotations. An algorithm is provided in the original guideline document at the ICSI Web site for Major Depression in Adults in Primary Care; clinical highlights and selected annotations (numbered to correspond with the algorithm) follow.
Class of evidence (Low Quality, Moderate Quality, High Quality, Meta-analysis, Systematic Review, Decision Analysis, Cost-Effectiveness Analysis, Guideline, and Reference) ratings are defined at the end of the "Major Recommendations" field.
Clinical Highlights
- A reasonable way to evaluate whether a system is successfully functioning in its diagnosis, treatment plan, and follow-up of major depression is to consider:
- How well the diagnosis is documented
- How well the treatment team engages and educates patients/families
- How reliably the ongoing patient contacts occur and response/remission to treatment are documented
- How well the outcomes are measured and documented
(Introduction; Annotations #1, 2, 9, 10, 13; Aims #1, 2, 3)
- Use a standardized instrument to document depressive symptoms. Document baseline symptoms and severity to assist in evaluating future progress, including response and remission rates. (Annotation #1, 2; Aims #2, 3, 4, 5)
- Additional considerations that should be taken into account:
- Patients with a high risk of common comorbid depression conditions such as substance abuse, diabetes, cardiovascular disease and chronic pain should be screened for depression.
- Perinatal depression treatment involves a thorough risk-benefit assessment in order to minimize the risks of both depression and its treatment to the mother and child.
- Older persons and the cultural experiences of patients require special considerations regarding risk, assessment and treatment of depression.
(Annotation #7; Aims #4, 6)
- Antidepressant medications and/or referral for psychotherapy are recommended as treatment for major depression. Factors to consider in making treatment recommendations are symptom severity, presence of psychosocial stressors, presence of comorbid conditions, and patient preferences. Physical activity and active patient engagement are also useful in easing symptoms of major depression. (Annotation #9; Aim #5)
- If the primary care clinician is seeing incremental improvement, continue working with that patient to increase medication dosage or augment with psychotherapy or medication to reach remission. This can take up to three months. Studies have shown that depression can be treated successfully in primary care. (Annotation #9, 10, 13)
- For medication treatment, patients may show improvement at two weeks but need a longer length of time to really see response and remission. Most people treated for initial depression need to be on medication at least 6 to 12 months after adequate response to symptoms. Patients with recurrent depression need to be treated for three years or more. (Annotation #13)
- For psychotherapy treatment, 8 to 10 weeks of regular and frequent therapy may be required to show improvement. (Annotation #13)
- The key objectives of treatment are to:
- Achieve remission of symptoms in the acute treatment phase for major depression
- Reduce relapse and reduction of symptoms
- Return patient to previous level of occupational and psychosocial function
(Annotation # 11, 13; Aims #2, 3)
Major Depression in Adults in Primary Care Algorithm Annotations
- Suspect and Screen for Major Depression
Recommendations:
- Clinicians may need to suspect the diagnosis of major depression or dysthymia based on a profile of risk factors and common presentations even if the patients do not initially complain of a depressed mood.
- If depression is suspected on the basis of risk factors or common presentations, it is recommended that clinicians use a standardized instrument to document depressive symptoms and track treatment response.
Presentations for Major Depression Include:
- Multiple (more than five per year) medical visits
- Multiple unexplained symptoms
- Work or relationship dysfunction
- Dampened affect
- Changes in interpersonal relationships
- Poor behavioral follow-through with activities of daily living or prior treatment recommendations
- Weight gain or loss
- Sleep disturbance
- Fatigue
- Memory/other cognitive complaints such as difficulty concentrating or making decisions
- Irritable bowel syndrome
- Volunteered complaints of stress or mood disturbance
The close relationship of mind and body results in the presentation of medical illness with major depression in various forms:
- Medical illness may be a biological cause (e.g., thyroid disorder, stroke).
- Medical illness or patient's perception of his or her clinical condition and health-related quality of life may trigger a psychological reaction to prognosis, pain or disability (e.g., in a patient with cancer).
- Medical illness may exist coincidentally in a patient with primary mood or anxiety disorder.
- Since medical illness does co-exist in patients with primary mood or anxiety disorders, it is necessary that physical complaints not be dismissed and/or merely accounted for as part of the depression. Medical issues should still be specifically addressed, especially when new symptoms are reported.
See also Annotation #7, "Additional Considerations (Medical Comorbidity, Cultural Considerations, Special Populations)?" in the "Medical Comorbidity" section.
Risk Factors for Major Depression Include:
- Family or personal history of major depression and/or substance abuse
- Recent loss
- Chronic medical illness
- Stressful life events that include loss (death of a loved one, divorce)
- Traumatic events (car accident)
- Major life changes (job change, financial difficulties)
- Domestic abuse/violence
Emotional and behavioral reactions to these social stressors can include symptoms of major depression.
One previous episode of major depression is associated with a 50% chance of a subsequent episode, two episodes with a 70% chance, and three or more episodes with a 90% chance [Low Quality Evidence].
Most studies indicate that in 40% to 60% of patients, a major life event precedes the first episode of major depression [Low Quality Evidence].
Screening
Validated and reliable tools can help clinicians identify and systematically monitor patients with major depression. Screening and tracking tools should be used to enhance but not replace the clinical interview.
Patients with chronic illnesses such as diabetes, cardiovascular disease and chronic pain are at higher risk for depression. Either the Patient Health Questionnaire (PHQ)-2 or the PHQ-9 can be used to screen for depression. There is stronger evidence supporting the use of the PHQ-9 in patients with chronic disease.
Use the PHQ two-question tool in routine screening settings [Meta-analysis].
Over the past two weeks, have you been bothered by:
- Little interest or pleasure in doing things?
- Feeling down, depressed or hopeless?
If the patient answers "yes" to either of the above questions, administer the full PHQ-9 depression instrument [Systematic Review].
The PHQ-9 has been validated for measuring depression severity [Low Quality Evidence] and is validated as a tool for both detecting and monitoring depression in primary care settings [Systematic Review].
It can be administered telephonically [Low Quality Evidence] and read to the patient. Elderly patients with mild cognitive impairment can reliably fill out the PHQ-9 [Low Quality Evidence]. A recent study found the PHQ-9 useful in psychiatric practices, as well. PHQ-9 scores influenced clinical decision-making for 93% of more than 6,000 patient contacts [Low Quality Evidence].
The tool and many other language versions can be found at http://www.phqscreeners.com . When administering the PHQ-9, be aware of cultural factors and involve an interpreter if needed. As research develops on risk adjustment and stratification using this tool, the work group will report and refine recommendations. See also Annotation #7, "Additional Considerations (Medical Comorbidity, Cultural Considerations, Special Populations)?" for more information on cultural beliefs and common presentations.
Other examples that are recognized and validated are the Beck Depression Inventory, Hamilton Rating Scale for Depression (HAM-D), and the Quick Inventory of Depressive Symptomatology Self Report (QID-SR) [Low Quality Evidence]. Regardless, it is crucial to document that the patient meets the criteria of at least five symptoms for at least two weeks as defined by the "Diagnostic and Statistical Manual of Mental Disorders," 4th Edition Text Revision (DSM-IV TR) criteria for major depression. One of the symptoms must be depressed mood or loss of interest or pleasure. See Appendices B, C, E, F and G in the original guideline document for example questionnaires.
Clinicians should choose the method that best fits their personal preference, the patient population served, and the practice setting.
The primary objective is to use a standardized instrument that will quantify and document future progress, including response and remission rates.
- Diagnose and Characterize Major Depression with Clinical Interview
Depressed mood or anhedonia (diminished interest or pleasure in activities) is necessary to diagnose major depression.
The use of a mnemonic may likewise be helpful for remembering the symptoms of major depression and dysthymia. SIGECAPS or SIG + Energy + CAPSules is easily remembered and can be used in the clinical interview. It was developed by Dr. Carey Gross of Massachusetts General Hospital and stands for:
Sleep disorder (increased or decreased)
Interest deficit (anhedonia)
Guilt (worthlessness, hopelessness, regret)
Energy deficit
Concentration deficit
Appetite disorder (increased or decreased)
Psychomotor retardation or agitation
Suicidality
DMS-IV TR Criteria: Major Depressive Episode
- Five or more of the following symptoms have been present and documented during the same two-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.
Note: Do not include symptoms that are clearly due to a general medical condition, mood-congruent delusions, or hallucinations.
- Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feels sad or empty) or observation made by others (e.g., appears tearful)
- Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (as indicated by either subjective account or observation made by others)
- Significant weight loss when not dieting or weight gain (e.g., a change of more than 5% of body weight in a month), or decrease or increase in appetite nearly every day
- Insomnia or hypersomnia nearly every day
- Psychomotor agitation or retardation nearly every day (observable by others, not merely subjective feelings of restlessness or being slowed down)
- Fatigue or loss of energy nearly every day
- Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day (not merely self-reproach or guilt about being sick)
- Diminished ability to think or concentrate, or indecisiveness, nearly every day (either by subjective account or as observed by others)
- Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide
- The symptoms do not meet criteria for a mixed episode.
- The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.
- The symptoms are not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition (e.g., hypothyroidism).
- The symptoms are not better accounted for by bereavement (e.g., after the loss of a loved one), and the symptoms persist for longer than two months or are characterized by marked functional impairment, morbid preoccupation with worthlessness, suicidal ideation, psychotic symptoms, or psychomotor retardation.
The assessment of major depressive disorders should include the DSM-IV TR numerical rating of the disorder with all five digits, thus including a severity rating. For example, 296.22 (Major depressive disorder, single episode, moderate severity).
DMS-IV TR Criteria: Dysthymic Disorder
- Depressed mood for most of the day, for more days than not for at least two years.
- Presence while depressed of two or more of the following:
- Poor appetite or overeating
- Insomnia or hypersomnia
- Low energy or fatigue
- Low self-esteem
- Poor concentration or difficulty making decisions
- Feelings of hopelessness
- During the two-year period, the person has never been without the symptoms in A and B for more than two months at a time.
- No major depressive episode present during the first two years (disturbance is not better accounted for by chronic major depressive disorder or major depressive disorder in partial remission).
- Absence of a manic episode, mixed episode, or hypomanic episode, and criteria has never been met for cyclothymic disorder.
- Disturbance does not occur exclusively during the course of a chronic psychotic disorder.
- Symptoms are not due to the direct physiological effects of a substance or general medical condition.
- Symptoms cause clinically significant distress or impairment in social, occupational or other important areas of functioning.
The assessment of dysthymic disorder should include the DSM-IV TR numerical rating of the disorder with all five digits, including onset specifier [Guideline].
Depressive disorder not otherwise specified (Depression NOS), with a diagnosis code of 311, is designed for patients who do not meet criteria for major depression disorder, dysthymic disorder, adjustment disorder with depressed mood, or adjustment disorder with mixed anxiety and depressed mood - for example, patients with low-level intensity of depression (below the threshold for major clinical depression) that has been present for less than two years. Another example would be a woman with a pattern of depression that fits premenstrual dysphoric disorder. A patient with depressive episodes of at least two weeks but the symptoms are fewer than the five items required for major depressive disorder would best be designated in the Depression NOS category. A final example includes a situation in which the depressive disorder was present but one is unable to determine whether it is primary, due to a general medical condition, or due to substance-induced depression.
This is not a homogenous group of patients where there is evidence for best practice. If the patient meets criteria for major depressive disorder or dysthymic disorder, it is important to diagnose and code them as such in order to proceed with evidence-based treatment.
History of Present Illness
Determine history of present illness including:
- Onset may be gradual over months or years or may be abrupt.
- Severity of symptoms and degree of functional impairment:
People diagnosed with major depression have a heterogeneous course from self-limiting to life-threatening. Predictors of poor outcome include higher severity at initial assessment, lack of reduction of social difficulties at follow-up and low educational level. Categorize severity of symptoms and degree of functional impairment as follows:
Mild: few, if any, symptoms in excess of those required to make the diagnosis and only minor impairment in occupational and/or social functioning
Moderate: symptoms or functional impairment between mild and severe
Severe: several symptoms in excess of those necessary to make the diagnosis and marked interference with occupational and/or social functioning
- Number and severity of previous episodes, treatment responses and suicide attempts.
- Ask about concurrent psychiatric conditions. Obtaining a past psychiatric history is important in terms of understanding prognosis and risk factors. For example, knowledge of past episodes of major depression, past co-occurring mental/behavioral health conditions, and past self-harm attempts is important for establishing risk and need to involve other mental health professionals.
- Psychosocial stressors (significant loss, conflict, financial difficulties, life change, abuse). Consider duration and severity of stressor(s) and likelihood for spontaneous improvement. For short-term subclinical and mild cases, close follow-up and monitoring is still needed [Meta-analysis]. Ongoing utility of behavioral activation, skill building and self-management practices are recommended [Meta-analysis], [High Quality Evidence]
For more information, see Annotation #9, "Comprehensive Treatment Plan," sections titled "Behavioral Activation – Scheduled Pleasant Activities" and "Discuss Treatment Options."
Medical History
A past medical history and brief review of systems is generally sufficient to rule out medical disorders causing major depression. Pertinent medical history that may complicate pharmacological treatments include, for example, prostatism, cardiac conduction abnormalities, and impaired hepatic function.
Perform a focused physical examination and laboratory testing as indicated by the review of systems. The benefit of screening laboratory tests, including thyroid tests, to evaluate major depression has not been established.
Considerations of laboratory tests should be greater if:
- The medical review of systems detects symptoms that are rarely encountered in mood or anxiety disorders.
- The patient is older.
- The first major depressive episode occurs after the age of 40.
- The depression does not respond fully to routine treatment.
Medication History and Substance Abuse/Dependence
Determine medication history and substance abuse/dependence:
- Medications such as steroids, interferon, alpha-methyldopa, isotretinoin, varenicline, and hormonal therapy may be associated with major depression.
- Use of alcohol and hypnotics might mimic and/or induce depression, and comorbidity is common [High Quality Evidence].
- Withdrawal from cocaine, anxiolytics, and amphetamines may mimic depression.
- Idiosyncratic reactions to other medications can occur and if possible, a medication should be stopped or changed if depression develops after beginning its use. If symptoms persist after stopping or changing medication, reevaluate for a primary mood or anxiety disorder.
See the original guideline document for information about anxiety or somatoform disorder, adjustment disorder, and bipolar disorder.
- Is Patient Unsafe to Self or Others?
Assessing suicidal tendencies is a critical but often difficult process with a depressed patient. Consider asking and documenting the following progression of questions.
- Do you feel that life is worth living?
- Do you wish you were dead?
- Have you thought about ending your life?
- If yes, have you gone so far as to think about how you would do so? Be specific, what method would you use?
- Do you have access to a way to carry out your plan?
- What keeps you from harming yourself?
Many patients will not answer #4 directly or will add, "But I'd never do it." Give them positive feedback (e.g., "I'm glad to hear that") but do not drop the subject until she/he has told you the specific methods considered (e.g., gun, medication overdose, motor vehicle accident).
It is important for a health care clinic to develop its own suicide protocol, taking into account the organization's workflow and resources. A clear process for risk assessment, when to involve the on-call mental health clinician, use of local or national hotlines, next steps, etc., should be determined by each individual clinic.
A recommended resource for how to establish a clinic-based protocol to assess and minimize suicide risk is Bonner, L., et al. Suicide Risk Response: Enhancing Patient Safety Through Development of Effective Institutional Policies. Advances in Patient Safety: From Research to Implementation. Vol 3, February 2005 http://www.ahrq.gov/qual/advances/ .
See also Appendix D, "Example Suicidality Screening Flow," in the original guideline document.
Circumstances such as clear past examples of a sense of competence to execute an attempt, a sense of courage to make the attempt, behaviors that ensure the availability of means and opportunity to complete, concrete preparations to enact the suicide plan, and a current episode of severe depression combine to pose a greater danger of eventual completed suicide. The clinician should consider previous history of suicide attempts; chemical dependency; personality disorder and/or physical illness; family history of suicide; single status; recent loss by death, divorce or separation; insomnia; panic attacks and/or severe psychic anxiety; diminished concentration; anhedonia; hopelessness; post-traumatic stress disorder (PTSD); or suicidal ideation [Low Quality Evidence].
Patients with comorbid major depressive episode and PTSD are more likely to have attempted suicide. Women with both disorders were more likely than men with both disorders to attempt suicide [Low Quality Evidence].
- Assess Need for Additional Resources: Substance Abuse or Psychiatric Comorbidity?
History of Substance Abuse
Alcoholism and major depressive disorder are distinct clinical entities and are not different expressions of the same underlying condition. Within the general population, substance abuse prevalence ranges from 8% to 21% in people with major depression [High Quality Evidence].
Screening (CAGE, CAGE-AID, Alcohol Use Disorders Identification Test [AUDIT], AUDIT-C)
Current alcohol or other drug problems can be screened by asking a few questions that can be easily integrated into a clinical interview. The work group reviewed the literature on instruments designed to screen for substance use disorders. The CAGE questions are sensitive and specific for diagnosing alcoholism. One positive response has a sensitivity of 85% and a specificity of 89%, and two positive responses have a specificity of 96% [Low Quality Evidence]. The CAGE-AID questionnaire broadens the CAGE to include other drug use. The AUDIT screening tool accurately detects alcohol dependency in depressed/anxious men and women; however, the overall performance of the AUDIT in detecting alcohol abuse is limited [Low Quality Evidence]. The AUDIT-C, a modified version of the 10 question AUDIT instrument, can help identify persons who are hazardous drinkers or have active alcohol use disorders.
Other instruments that were reviewed included Michigan Alcohol Screening Test (MAST), Short Michigan Alcohol Screening Test (SMAST), SMAST Adjusted to Include Drugs (AID) (SMAST-AID).
See Appendix H, "Alcohol Use Disorders Identification Test (AUDIT) Structured Interview," in the original guideline document.
See the original guideline document for examples of other substance abuse screening tools.
Treatment
The medical literature does not support definitive statements about the best way(s) to treat patients who are diagnosed with both major depression and substance abuse/dependence. The majority of studies reviewed indicate that success in treating dependency on alcohol, cocaine, and other abused substances is more likely if accompanying depression is addressed. Fewer investigators have looked at whether treating substance abuse is helpful in reducing depression. There is some evidence that patients with major depression that is secondary to their substance abuse may have remission of their depressed mood once the substance abuse is treated. However, it is difficult to separate secondary depression from primary depression that predates or is separate from the substance use.
The algorithm reflects the uncertainty in this area. At diamond #5 it splits into two possible paths. If yes -- a depressed patient is felt to be chemically dependent and treatment of the substance abuse should be considered, either before or while treating the depression. However, if no -- a depressed patient refuses treatment for substance abuse, has a medical comorbidity, or is of a special population--it is appropriate to focus primarily on the depression--keeping the special circumstances in mind. It is reasonable to attempt to treat the depression while continuing to assist the patient to work toward efforts to understand special needs.
A complete discussion of evaluation and treatment for chemical dependency is beyond the scope of this guideline. However, SBIRT (Screening, Brief Intervention, Referral and Treatment) is a process wherein a care coordinator uses motivational interviewing to assist patients with high-risk drinking behavior. Additionally, the National Institute on Alcohol Abuse and Alcoholism and other agencies offer tools to guide primary care-based medical treatment of alcohol abuse. See Web site links in the original guideline document. A referral may be appropriate. For more information, see also the NGC summary of the ICSI guideline Healthy Lifestyles.
Psychiatric Comorbidity
Be aware of ongoing mental illness diagnosis or other mental health illnesses and comorbidities. Patients with a history of manic (bipolar) symptoms now presenting with major depression may be destabilized if treated only with antidepressant drugs. While treating a patient for depression, if a manic or hypomanic episode occurs, change the diagnosis to bipolar affective disorder and treat accordingly [Low Quality Evidence]. Behavioral health involvement is advised with these patients absent a prior history of successful primary care management. Major depression may also be associated with other psychiatric problems including personality disorders, anxiety disorders, obsessive-compulsive disorders, psychosis, eating disorders and substance abuse. Patients with these conditions may need specialty care services, and details of treatment are beyond the scope of this guideline. See Annotation #6, "Involve Behavioral/Chemical Health."
See also Appendix A, "Other Mood and Anxiety Disorders," in the original guideline document.
- Involve Behavioral/Chemical Health
Involve same-day behavioral health for:
- Suicidal thoughts and/or plans that make the clinician uncertain of the patient's safety
- Assaultive or homicidal thoughts and/or plans that make the clinician uncertain about the safety of the patient or others
- Recent loss of touch with reality (psychosis)
- Inability to care for self/family
Involvement could include:
- Appointment with psychiatrist and/or psychotherapist
- Phone consultation with psychiatrist and/or psychotherapist
- Referral to the emergency department [Low Quality Evidence]
- Additional Considerations (Medical Comorbidity, Cultural Considerations, Special Populations)?
Recommendations:
- Screening and treatment for depression in patients with some comorbidities is recommended.
- In those patients presenting with either pain or depressive symptoms, both domains should be assessed.
- Clinicians should acknowledge the impact of culture and cultural differences on physical and mental health.
- When using pharmacotherapy in elderly patients, the physician must carefully consider how the metabolism of the drug may be affected by physiologic changes, their comorbid illnesses and the medications used for them.
Medical Comorbidity
The importance of the interplay between depression and many medical comorbidities cannot be overstated. Depressed patients often have comorbid conditions. A long list of medical conditions has been associated with increased risk for depression; these include chronic pain, diabetes, cancer, human immunodeficiency virus (HIV), Parkinson's disease, cardiovascular and cerebrovascular disease, and multiple sclerosis, to name a few [Low Quality Evidence]. Undiagnosed or undertreated depression has been associated with worsened outcomes in cancer, cardiovascular disease, and other conditions [Low Quality Evidence], [Guideline]. Conversely, one would expect that effective identification and treatment of comorbid depression would be associated with improved medical outcomes. Studies have demonstrated an association between effective treatment of depression and improved adherence to medical treatment for conditions such as cardiovascular disease [Low Quality Evidence]. However, other suspected benefits of antidepressant therapy, such as decreased mortality after myocardial infarction (MI) or coronary artery bypass graft (CABG), have been more difficult to prove. See "Implementation Tools and Resources Table" in the original guideline document for more information.
The following conditions are particularly important for screening, given the findings.
Cardiovascular Disease
Some studies have shown that major depression is associated with an increased risk of developing coronary artery disease [Systematic Review], and with an increased risk of mortality in patients after myocardial infarction by as much as fourfold [Guideline], [Low Quality Evidence], while other analyses have disputed this [Low Quality Evidence], [Systematic Review]. Moderate to severe depression before CABG surgery and/or persistent depression after surgery increases the risk of death after CABG more than twofold higher than non-depressed patients [Low Quality Evidence]. Depression is three times more common in patients after acute myocardial infarction than in the general population and, notably, young women are at particularly high risk for depression after myocardial infarction [Guideline].
Several possible mechanisms are proposed to explain why depression increases the risk of developing cardiovascular disease including behavioral issues such as increased smoking, obesity, sedentary lifestyle, and lack of adherence to medication.
As yet there are no data to support the hypothesis that antidepressant treatment improves cardiac morbidity and mortality [Low Quality Evidence]. Nevertheless, consensus opinion is to treat depressed cardiac patients with a safe drug rather than watchful waiting since they would benefit from symptomatic relief of their depressive symptoms and there is a potential improvement in their cardiovascular risk profile [Low Quality Evidence].
Although tricyclic antidepressants are effective against depression, they are associated with cardiovascular side effects including orthostatic hypotension, slowed cardiac conduction, proarrhythmic activity, and increased heart rate. Selective serotonin reuptake inhibitors (SSRIs), by contrast, are well tolerated and have a more benign cardiovascular profile; they would be preferred initial agents for treatment of depression in individuals with cardiovascular disease [Low Quality Evidence]. The recent American Heart Association science advisory [Guideline] suggests sertraline and citalopram as first-line drugs for patients with coronary heart disease.
For more information, see also the NGC summaries of the ICSI guidelines Heart Failure in Adults and Stable Coronary Artery Disease.
Cerebrovascular Disease
A recent meta-analysis [Systematic Review] affirms earlier findings [Low Quality Evidence], [Systematic Review] of an association between depression and stroke. The pooled hazard ratios from the Pan study was 1.45, on par with the association between smoking and stroke, and obesity and stroke. The authors suggest potential causative mechanisms similar to those discussed above for cardiovascular disease. They also suggest the need for further studies to assess the "role of depression treatment in modulating subsequent risk of stroke."
Diabetes
Major depression is associated with an increased number of known cardiac risk factors in patients with diabetes and a higher incidence of coronary heart disease; therefore, screening and treatment of depression in this patient group should be emphasized [Low Quality Evidence].
Individuals with diabetes have two-fold higher odds of depression than those without diabetes. High levels of symptoms associated with diabetes that do not correlate with physical or laboratory assessments should prompt the physician to assess for depression [Low Quality Evidence].
Depression earlier in life increases the risk of developing diabetes by twofold [Low Quality Evidence].
Depressive symptom severity is associated with poorer diet, medication compliance, and self-care plus functional impairment and higher health care costs [Low Quality Evidence].
For more information, see also the NGC summary of the ICSI guideline Diagnosis and Management of Type 2 Diabetes Mellitus in Adults.
Chronic Pain
Depression and pain symptoms commonly coexist, exacerbate, or attenuate one another, and appear to share biological pathways and neurotransmitters. (See the original guideline document for information on important diagnostic and treatment findings regarding chronic pain.)
Key Clinical Practice Recommendations
- In those patients presenting with either pain or depressive symptoms, assess both domains. Depression may be more than a facet of chronic pain when significant depression symptoms are present. If comorbidity is found between chronic pain and mild to moderate major depression, treat both conditions for optimal outcomes [Low Quality Evidence]. If comorbid severe major depressive disorder is diagnosed concurrently with chronic pain, depressive symptoms should be the primary focus of treatment.
- Given that depression and pain symptoms appear to follow the same descending pathways of the central nervous system involving a functional deficiency of the neurotransmitters serotonin, norepinephrine, and dopamine, antidepressant medication is warranted, especially the dual-action tricyclic antidepressants such as amitriptyline or dual action atypical antidepressant reuptake inhibitors such as venlafaxine or duloxetine. Duloxetine is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy. Duloxetine, dosed orally at 60 mg once or twice daily, improved mean pain scores from baseline and increased the proportion of patients with at least 50% reduction in pain scores from baseline [High Quality Evidence].
- Combining pharmacologic treatment and cognitive-behavioral therapy appears to produce the most favorable treatment outcomes [Low Quality Evidence].
For more information, see also the NGC summary of the ICSI guideline Assessment and Management of Chronic Pain.
Cultural Considerations
- Successful care is most likely to occur when the provider uses appreciative inquiry by asking questions that produce positive potential and strengths, regarding the patient's cultural norms and beliefs, uses interpreters whenever possible, and seeks to incorporate the patient's beliefs into the treatment plan.
- A person's cultural and personal experiences influence his/her beliefs and therefore attitudes and preferences. If these experiences are taken into consideration, openness to and readiness to change (including readiness to seek and adhere to treatment) will be enhanced. People of differing racial/ethnic groups are successfully treated using currently available evidence-based interventions when differential personal elements, from biological to environmental to cultural, are considered during the treatment planning process [Low Quality Evidence].
- Online resources including http://www.culturecareconnection.org and http://minorityhealth.hhs.gov have readily available information and facts. See "Implementation Tools and Resources Table" section in the original guideline for more information.
See the original guideline document for information about cultural considerations regarding cultural beliefs and common presentations, ethnic minority women, African Americans, Latinos/Hispanics, Asians, psychosocial and socioeconomic issues, and assessment and treatment tools.
Special Populations
See the original guideline document for a discussion of special populations, including geriatrics, depression and dementia/cognitive impairment, and perinatal depression (including risk factors, treatment recommendations, and safety assessment of psychotropic medication).
- Address Secondary Causes and/or Adapt a Plan for the Special Population
People with secondary causes for major depression may also have an underlying primary mood or anxiety disorder. Understanding and addressing nuances of special populations may enhance treatment outcomes. See Annotation #5, "Assess Need for Additional Resources: Substance Abuse or Psychiatric Comorbidity?" and Annotation #7, "Additional Considerations (Medical Comorbidity, Cultural Considerations, Psychiatric Comorbidity)?"
- Comprehensive Treatment Plan
Recommendations:
- The Collaborative Care Model is recommended for depression in primary care because it has demonstrated improvement in treatment adherence, patient quality of life, and depression outcomes.
- Successful programs for the treatment of depression should include organized treatment protocols, structured follow-up protocols, systematic monitoring of treatment adherence, and effectiveness.
- When considering treatment options, the primary goal should be to achieve remission.
Collaborative Care Model
More than 37 randomized controlled trials have demonstrated the effectiveness of the Collaborative Care Model. The work group recommends three key references (see original guideline document [Meta-analysis], [High Quality Evidence]) in which primary care treatment of depression is provided by a team (depression care manager, primary physician, consulting psychiatrist, others). This model has demonstrated improvement in treatment adherence, patient quality of life, and depression outcomes. Beneficial impact on direct medical costs can also be found and further dissemination of this model has been recommended [R]. Preliminary evidence suggests the collaborative care model is also effective for depression during pregnancy and postpartum [Low Quality Evidence].
The design of a team-based collaborative care approach [High Quality Evidence] involves:
- Primary care providers using evidence-based approaches to depression care and a standard tool for measuring severity, response to treatment plan and remission
- A systematic way of tracking and reminding patients at appropriate intervals of visits with their primary care physician and monitoring of treatment adherence and effectiveness
- A team member (care manager role) to utilize the tracking system and make frequent contacts with the patients to provide further education, self-management support, and monitor for response in order to aid in facilitating treatment changes and in relapse prevention
- Communication between primary care team and psychiatry to consult frequently and regularly regarding patient under clinical supervision, as well as direct patient visits as needed
The use of a Collaborative Care Model can help with medication compliance, by providing closer follow-up than is possible without a care manager. Three or more follow-up visits in the first three months reduced the risk of relapse/recurrence of depression, as did continuous use of antidepressants [Low Quality Evidence]. Care management facilitates continuous use of antidepressants, by providing close follow-up and early intervention when side effects occur.
There are challenges in providing the Collaborative Care Model that need to be acknowledged and addressed by the health care organization. Some of these challenges include:
- Identifying depressed patients in the practice
- Identifying the desired background experience for care managers
- Establishing the responsibilities and scope of practice of the care managers
- Locating the care managers (centrally versus clinic-based)
- Deciding on type of care manager interaction of care managers desired with patients (telephonic versus face-to-face)
- Determining level of supervision by psychiatrists
- Seeking adequate reimbursement for services provided to ensure program sustainability
[Low Quality Evidence]
See the "Implementation Recommendations" (see the "Description of Implementation Strategy" field of this summary) and the "Implementation Tools and Resources Table" section of the original guideline document for suggestions and information on implementing the Collaborative Care Model.
Educate and Engage Patient
Successful care of major depression as an illness requires active engagement of each patient and his/her family and ongoing patient education, beginning at the time of diagnosis.
Often, the depressed patient's pessimism, low motivation, low energy, and sense of social isolation and guilt may lead to nonadherence with treatment [R].
Education topics should include:
- The cause, symptoms and natural history of major depression
- Treatment options and the process of finding the best fit for a given individual
- Information on what to expect during the course of treatment
- How to monitor symptoms and side effects
- Follow-up protocol (office visits and/or telephone contacts)
- Early warning signs of relapse or recurrence
- Length of treatment
- Communication with the caregiver. A patient should plan to make appointments for six months to one year. Frequency of visits will depend on depression severity. See "Establish Follow-Up Plan" further in this annotation.
Patient education should include diagnosis, prognosis, and treatment options including costs, duration, side effects, and expected benefits. While the goal of the PHQ-2 and PHQ-9 is detecting and diagnosing depression, they are, in real-world use, often used primarily in shared decision-making with patients to "suggest, tell, or convince patients to accept the diagnosis of depression" [Low Quality Evidence]. Support and education in the primary care setting are critical and contribute to the likelihood of good follow-through on treatment. It may help patients understand their options and resources if the primary care clinic explains that this is not the same as a course of psychotherapy. Emphasize the following points:
- Depression is a medical illness, not a character defect.
- Treatment is effective for most patients.
- The aim of treatment is remission - being predominately free of symptoms.
- Relapse prevention is a key aspect of management – not just getting better, but also staying well. The risk of recurrence is significant: 50% after one episode, 70% after two episodes, 90% after three episodes [Low Quality Evidence]. Patient and family should be alert to early signs and symptoms of recurrence and seek treatment early if depression returns.
People of differing racial/ethnic groups can be successfully treated using currently available evidence-based interventions when differential personal elements, from biological to environmental to cultural, are considered during the treatment planning process [Low Quality Evidence].
Patient Self-Management
It is important for the patient to consider and adopt some self-care responsibilities, which may range from simply demonstrating reliable behavior in taking medications and notifying the provider about side effects to agreeing to participate in sessions, or journaling and completing homework, which is necessary for some cognitive behavioral therapies. Written materials are helpful to reinforce information shared during the discussion. Bibliotherapy, a therapy approach wherein the patient is encouraged to read self-help books and other relevant materials, has modest empirical support for benefiting patients who are motivated to augment their professional care with self-help literature [Meta-analysis].
See the "Implementation Tools and Resources Table" section of the original guideline document for examples of book titles.
Behavioral Activation — Scheduled Pleasant Activities
Activity scheduling is a straightforward behavioral intervention in which patients are taught to increase their daily involvement in pleasant activities and to increase their positive interactions with the environment [Low Quality Evidence]. This is an attractive intervention for the treatment of depression because it is simple in concept, easily taught, efficient, and does not require complex skills on the part of either patient or clinician.
The relative simplicity of encouraging patients to increase their daily participation in pleasant activities makes activity scheduling an attractive treatment approach for otherwise difficult to treat populations such as depressed dementia patients. Regular outings and get-togethers, participation in a senior day care program, participation in available nursing home activities, etc., are all likely to reduce depression in the elderly [Meta-analysis].
Appropriate Physical Activity
Evidence suggests that physical activity at a dose consistent with public health recommendations is a useful tool for easing major depression symptoms [High Quality Evidence]. Exercise has been shown to work well as monotherapy or adjuvant to medication in moderate depression. Exercise has shown promise as adjuvant therapy in treatment-resistant major depression in women, and there is a small but growing body of evidence of some long-term as well as preventive attributes [High Quality Evidence]. When prescribing exercise either alone or as an adjunct to medication and psychotherapy, the complexity and the individual circumstances of each patient must be considered. When prescribing an exercise prescription, several caveats apply:
- Anticipate barriers - hopelessness and fatigue can make physical exertion difficult.
- Keep expectations realistic - some patients are vulnerable to guilt and self-blame if they fail to carry out the regime.
- Introduce a feasible plan - walking, alone or in a group, is often a good option.
- Accentuate pleasurable aspects - the specific choice of exercise should be guided by the patient's preferences, and must be pleasurable.
- A goal of 30 minutes of moderate-intensity aerobic exercise, three to five days a week is recommended for otherwise healthy adults (17.5 kcal/kg/week of total energy expenditure). For more information see the NGC summary of the ICSI guideline Prevention and Management of Obesity (Mature Adolescents and Adults).
- Encourage adherence - greater antidepressant effects are seen when training continues beyond 16 weeks. There is a central role in the patient-physician partnership in exploring antidepressant concerns, working with treatment preferences, and providing continued supportive management. A mismatch between patients' preferred and prescribed treatment acts as a significant barrier to sustained adherence [Low Quality Evidence]. Patient participation in shared treatment decision-making improves depression treatment adherence and clinical outcomes in depressed patients [Low Quality Evidence].
Discuss Treatment Options
When considering treatment options, the primary goal is to achieve remission or to get the patient to be predominately symptom free (i.e., a PHQ-9 score of less than five [Low Quality Evidence] or a Hamilton Rating Scale for Depression [HAMD]-17 score of less than or equal to 7 [Low Quality Evidence]).
Shared decision-making is a practice that guides patients, families, and physicians through a reliable process that incorporates patient values, priorities, and goals into discussions of risks and benefits of treatment options [Systematic Review]. There is evidence that mental health patients want to participate in health care decisions and to have more information about their illness and potential treatments [Low Quality Evidence]. Clinical guidelines and health policies are already advocating the use of shared decision-making for other conditions, in advance of evidence of positive effect, but further research is urgently needed in this area [Guideline]. There is at present a lack of good quality research evidence about the long-term effects of shared decision-making interventions in mental health conditions [Systematic Review].
Psychotherapy vs. Pharmacotherapy
If the initial presentation is mild to moderate, either an antidepressant or psychotherapy (or both) is indicated. If the presenting symptoms of depression are severe or chronic, the initial recommendation is to treat with antidepressants and psychotherapy. See the table "Translating PHQ-9 Depression Scores into Practice" in this annotation.
In mild to moderate levels of depression, psychotherapy can be equally as effective as medication [High Quality Evidence]. With severe depression, antidepressant medication may be necessary [High Quality Evidence]. In the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, cognitive behavioral therapy (CBT) had equal efficacy to the addition of another antidepressant medication, or to the switching of antidepressant medication, when the patient had not responded to the initial medication [Low Quality Evidence].
Factors to consider in making treatment recommendations are symptom severity and chronicity, presence of psychosocial stressors, presence of comorbid conditions, cultural/health beliefs, resource accessibility and sufficiency, and patient preferences. Patients who perceive more self-control of their health experience greater reduction in depressive symptoms, whether treated with psychotherapy or an antidepressant [Low Quality Evidence]. Results from a systematic review found clinical benefits when racial and ethnic minority female patients were allowed to choose their treatment (medication, psychotherapy or both) and were provided support and outreach services [Systematic Review]. Because both antidepressants and psychotherapy are effective, careful consideration of patient preference for mode of treatment is appropriate [High Quality Evidence]. (See the table "Translating PHQ-9 Depression Scores into Practice" in this annotation, and Annotation #7, "Additional Considerations (Medical Comorbidity, Cultural Considerations, Special Populations?")
Psychotherapy
As with all depression treatment, the goal of psychotherapy is to reach remission and prevent or minimize relapse. Offer a referral for psychotherapy whenever psychological or psychosocial issues are prominent, or if the patient requests it. CBT, interpersonal therapy (IPT), short-term psychodynamic psychotherapy (STPP) and problem-solving treatment (PST) have documented efficacy [Meta-analysis], [Low Quality Evidence], [High Quality Evidence]. Early research on Internet-delivered psychotherapy for depression in adults is also promising [Low Quality Evidence]. There is now significant evidence that psychotherapy plus medication is better than medication alone for moderate to severe unipolar depression [Meta-analysis]. Psychotherapy, especially focused psychotherapy, can significantly reduce symptoms, restore psychosocial and occupational functioning, and prevent relapse in patients with major depression [Meta-analysis]. Maintenance psychotherapy is useful in managing chronic forms of major depressive disorder [High Quality Evidence]. Evidence-based psychotherapy for depression does not specifically address treatment where there is comorbid anxiety.
If the patient is newly involved in psychotherapy, the following are important:
- Contact with patient in 4 to 6 weeks
- Communicate with therapist in 4 to 6 weeks
- Return visit in 8 to 10 weeks to evaluate progress
- It can take 8 to 10 weeks of regular and frequent therapy to show improvement
Complementary and Alternative Medicine Treatments
Acupuncture
Existing meta-analyses and systematic reviews vary with respect to acupuncture protocol (manual, electroacupuncture or sham), methodological soundness and efficacy results [Systematic Review]. Both sham and active acupuncture participants generally report symptomatic depression improvement [Systematic Review]. Serious adverse events from acupuncture are very uncommon, which may appeal to those who seek to avoid side effects associated with traditional treatments (e.g., medication side effects). Rigorous positive studies are needed before acupuncture can be recommended for the treatment of major depressive disorder.
Acupuncture and yoga are effective as adjunctive treatment to decrease severity of symptoms [Guideline].
Herbals and Dietary Supplements
Caution: Many drugs interact with St. John's wort, including other antidepressants, warfarin, oral contraceptives, antiretroviral, anti-cancer and anti-rejection drugs. Care should be taken to ask all patients what medications they are taking, including over-the-counter and supplements, to avoid these interactions.
Herbal products and nutritional supplements are not evaluated or regulated by the U.S. Food and Drug Administration for safety, efficacy, or bioavailability.
In a meta-analysis [Systematic Review], S-adenosylethione (Sam-E) and hypericum perforatum (St. John's wort) were found to have indications for mild to moderate depression but not major depression. Sam-E and St. John's wort should not be taken in combination with other antidepressant medications.
A number of researchers have published studies and review articles regarding an increased risk of depression in patients with low levels of zinc, omega-3 fatty acid, or magnesium. Unfortunately, studies on appropriate supplementation of these dietary aides are often inconsistent in their design and results. While the replacement of zinc, magnesium and omega-3 fatty acid in patients with known deficiencies and who have major depression is often recommended, the exact dosages and durations of supplementation are not known [Systematic Review], [Low Quality Evidence].
A recent meta-analysis of randomized, placebo-controlled trials of omega-3 fatty acid (FA) in the treatment of major depressive disorder demonstrated no significant benefit of omega-3 FA treatment compared to placebo and significant heterogeneity in study design, as well as publication bias [Systematic Review].
At this time, there is insufficient evidence on the antidepressant effects of vitamin D [Low Quality Evidence].
Medications
The acute treatment phase is focused on treating the patient to remission. Acute therapy typically lasts 6-12 weeks but technically lasts until remission is reached [Guideline]. Full remission is defined as a two-month period devoid of major depressive signs and symptoms [Guideline].
For antidepressant medications, adherence to a therapeutic dose and meeting clinical goals are more important than the specific drug selected. Successful treatment often involves dosage adjustments and/or trial of a different medication at some point, to maximize response and minimize side effects [Guideline].
When antidepressant therapy is prescribed, the following key messages should be highlighted to support medication adherence and completion:
- Side effects from medication often precede therapeutic benefit and typically recede over time. It is important to expect some discomfort prior to the benefit.
- Successful treatment often involves dosage adjustments and/or trial of a different medication at some point, to maximize response and minimize side effects.
- Most people need to be on medication at least 6 to 12 months after adequate response to symptoms.
- Patients may show improvement at two weeks but need a longer length of time to really see response and remission.
- Take the medication as prescribed, even after one feels better. Premature discontinuation of antidepressant treatment has been associated with a 77% increase in the risk of relapse/recurrence of symptoms [Low Quality Evidence]. The probability of recurrence of depressive symptoms was found to be 25% after one year, 42% after two years, and 60% after five years in one study [Low Quality Evidence]. Each episode of recurrence increased the risk of subsequent episodes by 16% [Low Quality Evidence].
- Do not stop taking the medication without calling your clinician. Side effects can be managed by changes in the dosage or dosage schedule.
Patient adherence is critical. Consider increasing education, engagement, and follow-up for patients who are at higher risk for not adhering to treatment. For antidepressant treatment this includes patients who are newly diagnosed with depression, in the midst of their first depression, or who have lapsed in the middle of a previous course of treatment [Low Quality Evidence]. In addition to medication monitoring, clinical management of patients placed on antidepressants should include the clinician's support and reassurance.
The U.S. Food and Drug Administration has requested manufacturers of antidepressants include a warning statement regarding antidepressants increasing the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults. The full warning statement can be found at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 . FDA-approved medication guides are required to be distributed to patients who receive antidepressants. A complete list of specific medication guides can be found at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 .
Health care clinicians should carefully evaluate their patient in whom depression persistently worsens, or emergent suicidality is severe, abrupt in onset, or was not part of the presenting symptoms to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated.
The clinician should instruct the patient and the patient's caregiver to be alert for the emergence of agitation, irritability, and the other symptoms. The emergence of suicidality and worsening depression should be closely monitored and reported immediately to the clinician.
See also Annotation #3, "Is Patient Unsafe to Self or Others?" above.
Selection of an Antidepressant Medication
The effectiveness of antidepressant medications is generally comparable between classes and within classes of medications [Guideline]. However, there are distinct differences inside effects caused by the classes of medications and individual agents.
Antidepressant drug selection should be based on:
- The patient's and family history of response to previous antidepressant medications (if any)
- Clinician experience with specific antidepressants
- Patient preferences
- Side effect profile (e.g., sedating, activating, weight gain, impact on sex life). Antidepressant medications with anticholinergic side effects contribute to dry mouth/xerostomia, caries, gingivitis, and periodontal disease [Low Quality Evidence]. This risk should be discussed with patients prior to initiation of these medications.
- Safety in overdose (e.g., ten days of a tricyclic antidepressant [TCA] can be a lethal overdose)
- Availability and costs
- Drug-drug interactions
- Positive or negative impacts on the patient's comorbid psychiatric or medical conditions (for example, smoking cessation, attention deficit hyperactivity disorder [ADHD])
- Anxiety
For the treatment of comorbid depression and anxiety, selective serotonin reuptake inhibitors (SSRIs) have comparable efficacy to the TCAs, even when anxiety symptoms are considered. Consider an anxiolytic or sedative-hypnotic medication such as buspirone. If acute relief is needed, consider a benzodiazepine for short-term usage. Benzodiazepines are not recommended for long-term use. Careful monitoring and medication selection is needed for individuals with co-occurring substance use disorders.
- Insomnia
When selecting an antidepressant in a patient whose symptoms include insomnia, consider prescribing a sedating antidepressant (e.g., trazodone, mirtazapine). If acute relief is needed, consider a benzodiazepine for short-term usage, but it is not recommended for long-term use. Also consider selective gamma-Aminobutyric acid (GABA) agonist hypnotic (e.g., zolpidem, eszopiclone). The most common side effect of mirtazapine is sedation. It may be prescribed for depressed patients with initial insomnia and given at bedtime.
The Texas Medication Algorithm Project (TMAP) provides good overall parameters for care. See the "Implementation Tools and Resources Table" in the original guideline for more information. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study has updated data on treatment response timelines and follow-ups.
There is no evidence regarding choice of brand versus generic based on adverse clinical outcomes.
While genetic differences in the metabolism of certain medications including antidepressants can be determined by genetic testing, the clinical significance and applicability to practice has not yet been established.
For up-to-date prescribing information, the work group recommends the following references:
Consider discussing with the patient the specific side effect profiles, costs, and benefits of different antidepressants, including generics. Cost implications for patients need to be discussed between provider and patient.
Selective Serotonin Reuptake Inhibitors and Other Antidepressants
SSRIs — as well as venlafaxine, duloxetine, desvenlafaxine, mirtazapine and bupropion — are frequently recommended as first-line antidepressant treatment options due to the quality and quantity of published data, and relative tolerability of side effects compared to TCAs and monoamine oxidase inhibitors (MAOIs) and their overall relative safety [Guideline], [Low Quality Evidence]. They generally lack the common adverse reactions (anticholinergic, sedative effects) of the tricyclics and cause fewer problems when taken in overdose. However, they may cause headache, nervousness, insomnia, and sexual side effects and may be more expensive because some may not yet be available as generics.
Secondary Amine Tricyclics
The literature clearly supports the effectiveness of tricyclics. Because of associated side effects, they are used less frequently as first-line agents.
Secondary (nortriptyline) amine tricyclics cause less orthostatic hypotension and sedation than do tertiary (amitriptyline) amine tricyclics.
These medications should be monitored cautiously in patients with heart problems, or in patients with potential for drug interactions. Monitoring blood levels and electrocardiogram (EKG) may be advised.
Monoamine Oxidase Inhibitors (MAOIs)
MAOIs, in general, should be restricted for patients who do not respond to other treatments because of their potential for serious side effects and the necessity of dietary restrictions. Patients with major depressive disorders with atypical features are one group for whom several studies suggest MAOIs may be particularly effective. However, in clinical practice, many psychiatrists start with SSRIs in such patients because of the more favorable adverse effect profile. Consider a dietary and/or psychiatry consult if prescribing MAOIs.
Atypical Antipsychotics
There is some evidence regarding the use of quetiapine as monotherapy for the treatment of major depression [Systematic Review].
See the original guideline document for information on serotonin syndrome, medication interactions with antidepressant agents, and consideration of antidepressants in elderly patients.
Establish Follow-Up Plan
Proactive follow-up contacts (in person, telephone) based on the Collaborative Care Model have been shown to significantly lower depression severity [High Quality Evidence]. In the available clinical effectiveness trials conducted in real clinical practice settings, even the addition of a care manager leads to modest remission rates [High Quality Evidence]. Interventions are critical to educating the patient regarding the importance of preventing relapse, safety and efficacy of medications and management of potential side effects. Establish and maintain initial follow-up contact intervals (office, phone, other) [High Quality Evidence].
The PHQ-9 is an effective management tool, as well, and should be used routinely for subsequent visits to monitor treatment outcomes and severity. It can also help the provider decide if/how to modify the treatment plan [Low Quality Evidence]. Using a measurement-based approach to depression care, PHQ-9 results and side effect evaluation should be combined with treatment algorithms to drive patients towards remission, for evaluating progress, a five-point drop in PHQ-9 score is considered the minimally clinical significant difference [Low Quality Evidence].
Table. Translating Patient Health Questionnaire, 9-Item (PHQ-9) Depression Scores into Practice
PHQ-9
Symptoms and Impairment
|
PHQ-9 Severity |
Provisional Diagnosis* |
Treatment Recommendations** |
| 1 to 4 symptoms, functional impairment |
5-9 |
Mild or Minimal Depressive Symptoms |
- Education to call if deteriorates
- Physical activity
- Behavioral activation
- If no improvement after one or more months, consider referral to behavioral health for evaluation
|
| 2 to 4 symptoms, question 1 or 2 +, functional impairment |
10-14 |
Mild Major Depression |
- Pharmacotherapy or psychotherapy
- Education
- Physical activity
- Behavioral activation
- Initially weekly contacts to ensure adequate engagement, then at least monthly
|
| ≥5 symptoms, question 1 or 2 +, functional impairment |
15-19 |
Moderate Major Depression |
- Pharmacotherapy and/or psychotherapy
- Education
- Physical activity
- Behavioral activation
- Initially consider weekly contacts to ensure adequate engagement, then minimum every 2-4 weeks
|
| ≥5 symptoms, question 1 or 2 +, functional impairment |
≥20 |
Severe Major Depression |
- Pharmacotherapy necessary and psychotherapy when patient able to participate
- Education
- Physical activity
- Behavioral activation
- Weekly contacts until less severe
|
This table is designed to translate the PHQ-9 scores into DSM-IV TR categories and then integrate evidence-based best practice. It does not directly correspond to the PHQ-9 Scoring Guide in Appendix B, "Patient Health Questionnaire (PHQ-9)," of the original guideline document.
[Meta-analysis], [Low Quality Evidence], [Systematic Review]
*Dysthymia is defined as low-level depression most of the day for more days than not for at least two years. Must include presence of at least two of the listed DSM-IV TR criteria affecting appetite, sleep, fatigue, self esteem, concentration/decision-making, hopelessness). Initiate pharmacotherapy or refer to mental health specialty clinician for evaluation. See also Annotation #2, "Diagnose and Characterize Major Depression with Clinical Interview."
**Referral or co-management with mental health specialty clinician if patient has:
- High suicide risk
- Inadequate treatment response
- Other psychiatric disorders such as bipolar, substance abuse, etc.
- Complex psychosocial needs
If the primary care provider is seeing some improvement, continue working with that patient to increase medication dosage or augment with psychotherapy or medication to reach remission. This can take up to three months. Don't give up on the patient whether treating in primary care or referring. Stay connected through consultation or collaboration and take the steps needed to get the patient to remission. This can take longer and can take several medication interventions or other steps. The STAR*D study has shown that primary care can be just as successful as specialty care [High Quality Evidence].
Relapse Prevention
The prevention of relapse is of primary importance in the treatment of major depression. From 50% to 85% of people who suffer an episode of major depression will have a recurrence, usually within two or three years. Patients who have had three or more episodes of major depression are at 90% risk of having another episode. Relapse prevention interventions resulted in 13.9 additional depression-free days during a 12-month period [High Quality Evidence].
Focused psychotherapy through cognitive-behavioral therapy can reduce relapse by assisting patients with their depression-related beliefs [High Quality Evidence]. In addition, focused psychotherapy can significantly reduce symptoms, and restore psychosocial and occupational functioning, in patients with major depression [Meta-analysis].
Collaboration with Mental Health
Consider collaborating with a behavioral health care clinician for the following:
- Patient request for psychotherapy
- Presence of severe symptoms and impairment in patient, or high suicide risk
- Presence of other psychiatric condition (e.g., personality disorder, history of mania)
- Suspicion or history of substance abuse
- Clinician discomfort with the case
- Medication advice (psychiatrist or other mental health prescriber)
- Patient request for more specialized treatment
- Is Patient Responding Adequately?
The goal of treatment should be to achieve remission, reduce relapse and recurrence, and return to previous level of occupational and psychosocial function.
Remission is defined as the absence of depressive symptoms, or the presence of minimal depressive symptoms such as HAM-D score of less than 7 or a PHQ-9 score of less than 5. Response is defined as a 50% or greater reduction in symptoms (as measured on a standardized rating scale) and partial response is defined as a 25% to 50% reduction in symptoms.
Results from the STAR*D study showed that remission rates lowered with more treatment steps, but the overall cumulative rate was 67% [High Quality Evidence].
In the STAR*D study, longer times than expected were needed to reach response or remission. In fact, one-third of those who ultimately responded did so after six weeks. Of those who achieved Quick Inventory of Depressive Symptomatology (QIDS) remission, 50% did so only at or after six weeks of treatment [High Quality Evidence]. If primary care clinician is seeing some improvement, continue working with that patient to augment or increase dosage to reach remission. This can take up to three months.
A reasonable criterion for extending the initial treatment is if the patient is experiencing a 25% or greater reduction in baseline symptom severity at six weeks of therapeutic dose. If the patient's symptoms are reduced by 25% or more, but the patient is not yet at remission, and if medication has been well tolerated, continue to prescribe. Raising the dose is recommended [High Quality Evidence]. Improvement with psychotherapy is often a bit slower than with pharmacotherapy. A decision regarding progress with psychotherapy and the need to change or augment this type of treatment may require 8 to 10 weeks before evaluation [Low Quality Evidence].
- Evaluate Dose, Duration, Type and Adherence with Medication and/or Psychotherapy. Reconsider Accuracy of Diagnosis or Impact of Comorbidities
If remission has not been achieved when reevaluated up to six weeks later, consider:
- Reevaluating the diagnosis.
- The possibility of a bipolar diathesis. Bipolar patients require a different treatment approach and may not consistently come forward with their hypomanic, mixed, or manic histories [Low Quality Evidence].
- Looking for comorbidities, such as substance abuse issues, and involve addiction specialists as needed.
- Consult with a behavioral health clinician if there are personality disorders present.
- Whether adequate engagement of patient/family is present and that recommendations are being followed (adherence).
- Adding cognitive psychotherapy or adding another medication such as buspirone or bupropion. Both augmentation strategies showed similar improvement rates in the STAR*D study; however, the addition of medication resulted in a significantly more rapid response [High Quality Evidence].
- Switching to a different antidepressant medication. After a failed trial of citalopram, remission rates in the STAR*D studies were 21.3% for bupropion sustained release (SR), 17.6% for sertraline, and 24.8% for venlafaxine XR [High Quality Evidence] although the differences were not statistically significant. Failure of a drug in one family does not rule out possible benefit from other drugs in that family. This is particularly true for SSRIs [Low Quality Evidence].
- Augmentation strategies (such as lithium or low-dose thyroid). See Annotation #12, "Consider Other Strategies" below.
- Referral to psychiatry for possible MAOI or electroconvulsive treatment (ECT). Many patients unresponsive to tricyclics are responsive to MAOIs. Rarely, the combination of tricyclics and MAOIs is used. This combination should be undertaken with extreme caution. Studies measuring response to MAOIs in SSRI non-responders have not been done [Low Quality Evidence], [High Quality Evidence]. See Annotation #12, "Consider Other Strategies."
A switch from an antidepressant to psychotherapy or vice versa appears useful for non-responders to initial treatment [Low Quality Evidence]. If there is less than 25% reduction of symptoms after six weeks at therapeutic dose (i.e., partial positive response to medication), add, switch or substitute another treatment modality. If there is a partial medication response and side effects are not prohibitive, increase the dose. As part of the evaluation, use a standardized assessment tool to gauge progress.
Pharmacologic Therapy
Without long-term antidepressant treatment, major depressive relapses and recurrences occur in 50% to 80% of patients. Double-blind discontinuation studies reveal that antidepressants decrease the risk of relapse and recurrence and have repeatedly shown antidepressants to be more efficacious than placebo substitution.
It has been well established that raising the dose of tricyclics or MAOIs may improve response. Similarly, a controlled study showed that raising the dose of fluoxetine (from 20 mg to 40 or 60 mg) in partially responsive patients was more effective than adding desipramine (25 to 50 mg per day) or lithium (300 to 600 mg daily). In non-responders, raising the fluoxetine dose was as effective as adding lithium, and both were more effective than adding desipramine [High Quality Evidence], [Low Quality Evidence].
One study with a tricyclic antidepressant showed decreased risk of relapse after 18 months of treatment [Low Quality Evidence].
Surveys of patient populations have indicated that patients receiving prescriptions for one of the benzodiazepines or other minor tranquilizers or hypnotics tend to use less than prescribed and to reduce their use over time. Benzodiazepine abuse is usually seen as part of a pattern of abuse of multiple drugs often involving alcohol and sometimes opioids [Low Quality Evidence].
See also "Discuss Treatment Options" section in Annotation #9 and Annotation #13, "Continuation and Maintenance Treatment Duration Based on Episode."
- Consider Other Strategies
Recommendations:
- Augmentation strategies may be considered for partial responders and combinations of antidepressants (when each has a different mechanism) have been shown to be options in those who fail to achieve remission.
- Partial or full hospitalization may be considered in patients who have not responded to outpatient management, particularly if safety issues are a concern.
- Use of bright light therapy for treatment of major depression with a seasonal specifier is recommended.
- Electroconvulsive treatment is effective and can sometimes be administered safely in an outpatient setting.
Treatment-resistant depression has several definitions in the literature. It is important to distinguish treatment resistance from a lack of completion of a full course of treatment. The literature further tends to focus on pharmacological treatments in the definition of treatment resistance without consistently incorporating psychotherapeutic modalities. True treatment resistance is seen as occurring on a continuum, from failure to reach remission after an adequate trial of a single antidepressant to failure to achieve remission despite several trials of antidepressants, augmentation strategies, ECT and psychotherapy. For the purposes of making recommendations for primary care clinicians, the guideline developers define true treatment resistance as failure to achieve remission with an adequate trial of therapy and three different classes of antidepressants at adequate duration and dosage [High Quality Evidence], [Low Quality Evidence], [Systematic Review].
Augmentation Therapy
Augmentation therapy is used for those situations where the patient's depression is either treatment-resistant or partially responsive to treatment. This is a good time to consult and/or refer to a behavioral health specialist.
Augmentation methods include:
- Bupropion or buspirone-SSRI combination [High Quality Evidence], [Low Quality Evidence]
- Mirtazapine-SSRI combination [High Quality Evidence], [Low Quality Evidence]
- Triiodothyronine (T3) augmentation of antidepressants [High Quality Evidence], [Low Quality Evidence]
- Stimulant augmentation of TCA-SSRI ("jump-start response") [Low Quality Evidence], [High Quality Evidence], [Systematic Review]
- TCA-SSRI combination (caution — elevated TCA level – to be monitored) [Low Quality Evidence]
- Lithium augmentation with TCAs. Lithium augmentation with SSRI (caution — case reports of serotonin syndrome) [High Quality Evidence], [Low Quality Evidence]
- Atypical antipsychotic-antidepressant combination [Systematic Review], [Meta-analysis], [High Quality Evidence]
Hospitalization
Partial or full hospitalization may be indicated in patients with unrelenting depressive symptoms, particularly if safety issues are a concern.
The following other strategies are most commonly referred in a primary care setting. For other specialized therapies, see Appendix I, "Specialized Therapies," in the original guideline document.
Electroconvulsive Treatment (ECT)
Response and remission rates are higher with ECT than with any other form of antidepressant treatment with 70%-90% of patients showing improvement [High Quality Evidence], [Systematic Review]. Electroconvulsive treatment is usually performed on an inpatient basis, but for some individuals, it can be administered safely in an outpatient setting. A patient considering ECT would need to be able to tolerate anesthesia, and should consult with a psychiatrist about the risks and benefits [Systematic Review], [High Quality Evidence].
In addition to its use as a treatment in the acute phase, ECT is an effective maintenance therapy for major depression. When comparing continuous ECT versus nortriptyline and lithium treatment, there was no difference in relapse [High Quality Evidence].
ECT is also effective for treating major mental illness during pregnancy, and the risks of adverse events are low. It should be strongly considered in pregnant women with severe symptoms of mental illness, such as psychotic symptoms, catatonia or strong suicidal urges [Systematic Review].
Factors that may suggest a given patient may be an ECT candidate include:
- Geriatric depression [Systematic Review]
- If antidepressant medications have not been tolerated or pose a significant medical risk
- If antidepressant medication trials have not been successful
- If ECT has been successful in previous episodes
- If catatonia is present
- When a rapid response is needed because of severe suicide risk or because the patient's health has been significantly compromised by the depression (e.g., severe cachexia, inability to attend to the activities of everyday living). ECT has been shown to be effective in resolving expressed suicidal intent [High Quality Evidence].
- If depression with psychotic features
- If melancholic symptoms are predominant
- Depression and Parkinsonism
[Guideline]
Common side effects associated with ECT include headaches, myalgias, nausea, drowsiness, confusion, and amnesia. More serious and rare side effects include hypertension, tachycardia, myocardial infarction, cerebrovascular accident, or death.
Light Therapy
Use of bright light therapy for treatment of major depression with a seasonal specifier is well established [High Quality Evidence], [Meta-analysis]. Additionally, there is evidence to support the use of bright light therapy for other types of depressive symptom patterns, including non-seasonal depression and milder variations of seasonal depressive patterns [Systematic Review], [High Quality Evidence]. For non-seasonal depression, light therapy's benefit as an adjunctive treatment is more robust than its benefit as monotherapy [Systematic Review]. Bright light therapy may also quicken and enhance the effects of antidepressant medication [High Quality Evidence]. In two small pilot studies, promising results were seen in pregnant and postpartum women with non-seasonal depression [High Quality Evidence], [Low Quality Evidence]. The standard starting dose for depression with a seasonal specifier is 10,000 lux for 30 minutes each morning [Systematic Review]. Research on bright light therapy for other types of depression has not necessarily utilized standard dosages and exposure times. The most common side effects are nausea, jitteriness, and headache [Systematic Review]. It is important for light therapy treatment to utilize equipment that eliminates ultraviolet frequencies and produces bright light of known spectrum and intensity. For these reasons, use of client-constructed light therapy units is contraindicated. The American Psychiatric Association (APA) Task Force concluded that "light therapy is an evidence-based, effective, well-tolerated treatment for seasonal affective disorder, as well as an augmentation strategy for antidepressant treatment of nonseasonal depression" [Systematic Review].
See Appendix I, "Specialized Therapies," in the original guideline document.
- Continuation and Maintenance Treatment Duration Based on Episode
Skill building and self-management practices learned through behavioral activation and other beneficial cognitive, behavioral, social, and exercise activities are recommended for continuation and maintenance of depression treatment [Meta-analysis], [High Quality Evidence], [Systematic Review]. Recent studies demonstrate an enduring benefit of cognitive therapy and behavioral activation comparable to maintenance pharmacotherapy in reducing major depressive episode relapse and recurrence beyond one year of treatment [High Quality Evidence]. Patients withdrawn from cognitive therapy were significantly less likely to relapse compared to patients withdrawn from pharmacotherapy; furthermore, those withdrawn from cognitive therapy were no more likely to relapse than those who continued pharmacotherapy [High Quality Evidence]. For patients who reached remission but had periodic depressive symptoms (defined as unstable remission), mindfulness based cognitive therapy or continuation pharmacotherapy significantly reduced depression relapse and recurrence rates [High Quality Evidence].
Acute therapy is the treatment phase focused on treating the patient to remission. Acute therapy typically lasts 6-12 weeks but technically lasts until remission is reached [Guideline]. Full remission is defined as a two-month period devoid of major depressive signs and symptoms [Guideline].
Continuation therapy is the 4-9 month period beyond the acute treatment phase during which the patient is treated with antidepressants, psychotherapy, ECT, or other somatic therapies to prevent relapse [Guideline]. Relapse is common within the first six months following remission from an acute depressive episode; as many as 20%-85% may relapse [Guideline].
Maintenance therapy is the treatment phase that follows continuation therapy. The goal of maintenance therapy is to prevent recurrence of new or future episodes of major depression [Low Quality Evidence]. The best candidates for maintenance therapy are patients who have had three or more previous episodes of major depression, have had two episodes of major depression but have also had rapid recurrence of episodes, or are older in age at the onset of major depression (more than 60 years of age), have had severe episodes of major depression, have a family history of a mood disorder, or have residual symptoms [Guideline]. Other risk factors for recurrence include the presence of a general medical condition, ongoing psychosocial stressors, negative cognitive styles, and persistent sleep disturbance [Guideline]. Maintenance therapy should also be considered for at-risk patients with double depression and patients with comorbid anxiety disorder or substance abuse. Patients whose major depression has a seasonal pattern are also at risk for recurrence and may benefit from seasonal reinstatement of light therapy or antidepressant therapy. For maintenance medication, contacts can occur every 3 to 12 months if everything else is stable [Low Quality Evidence], [High Quality Evidence].
Pharmacotherapy
The dose of antidepressant medication that leads to satisfactory acute therapeutic response should be maintained during long-term treatment to reduce the risk for relapse and recurrence of depression [Low Quality Evidence], [High Quality Evidence].
When considering how long to continue medication after the remission of acute symptoms, two issues need to be considered: maintenance and prophylactic treatment. Patients who require several medication changes to achieve remission of an acute major depressive episode have a higher rate of relapse and a shorter period of time until relapse in comparison to patients who require fewer medication changes to achieve remission [High Quality Evidence].
There are significant data to support the efficacy of antidepressants in preventing the recurrence of a major depressive episode. Although more research needs to be conducted, findings indicate that patients who are at highest risk of future episodes have had multiple prior episodes or were older at the time of the initial episode [High Quality Evidence]. These patients are candidates for long-term or lifetime prophylactic treatment.
For use of antidepressant medication, the following is recommended:
Table. Depression Treatment Duration Based on Episode (see original guideline document for International Classification of Disease (ICD)-9 codes associated with each episode)
| Episode |
Treatment Duration* |
| 1st episode (Major Depression, single episode) |
- Acute phase typically lasts 6-12 weeks.
- Continue psychotherapy/medication treatment for 4-9 months once remission is reached.
- Total = approximately 6-12 months
|
| 2nd episode (Major Depression, recurrent) |
Continue medication treatment for 3 years once remission is reached. Withdraw gradually. |
Dysthymia or 3+ episodes or 2 episodes (Major Depression, recurrent) with complicating factors such as:
- Rapid recurrence of episodes
- More than 60 years of age at onset of major depression
- Severe episodes or family history
|
Continue medication treatment indefinitely. |
[Guideline], [High Quality Evidence]
*Treat to remission. Full remission is defined as a two-month absence of symptoms.
Analysis suggests that recurrence rates are reduced by 70% when patients are maintained on antidepressants for three years following their previous episode (average recurrence on placebo 41% versus 18% on active treatment) [Low Quality Evidence].
Premature treatment discontinuation can be triggered by a number of factors, including lack of adequate education about the disease, failure on the part of either physician or the patient to establish goals for follow-up, psychosocial factors, and adverse side effects. Appropriate ongoing collaborative care for depression can increase remission rates to as much as 76% by 24 months [High Quality Evidence].
Complicating factors are those situations where evidence either shows or suggests higher rates of recurrence after stopping antidepressants and include:
- Pre-existing dysthymia
- Inability to achieve remission
- Recurrence of symptoms in response to previously attempted lowering dose or discontinuation [Low Quality Evidence]
If discontinuation of treatment is thought to be appropriate or necessary despite the known risks, a plan of action should be in place for prompt intervention if relapse occurs [Low Quality Evidence].
With the wide array of half-lives and therapeutic dose ranges for the various existing antidepressants, it is beyond the scope of this guideline to discuss detailed discontinuation strategies.
When feasible (e.g., the starting dose is not the same as therapeutic doses), it is recommended that the dose be tapered over a period of weeks to several months when discontinuing an antidepressant.
See also "Establish Follow-Up Plan" in Annotation #9 and Annotation #11, "Evaluate Dose, Duration, Type and Adherence with Medication and/or Psychotherapy. Reconsider Accuracy of Diagnosis and Impact of Comorbidities."
Definitions:
Following a review of several evidence rating and recommendation writing systems, the Institute for Clinical Systems Improvement (ICSI) has made a decision to transition to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.
Crosswalk between ICSI Evidence Grading System and GRADE
| Design of Study Current ICSI System |
ICSI GRADE System |
| |
| Class A: |
Randomized, controlled trial |
High, if no limitation |
| Moderate, if some limitations |
| Low, if serious limitations |
| |
| Class B: |
[observational] |
|
| Cohort study |
High, if well done with large effect |
| Moderate, if well done with effect |
| Low, most studies |
| |
| Class C: |
[observational] |
|
| Non-randomized trial with concurrent or historical controls |
|
| Case-control study |
Low |
| Population-based descriptive study |
Low |
| Study of sensitivity and specificity of a diagnostic test |
Low* |
| *Following individual study review, may be elevated to Moderate or High depending upon study design. |
| |
| Class D: |
[observational] |
|
| Cross-sectional study |
Low |
| Case series |
|
| Case report |
|
| |
| Class M: |
Meta-analysis |
Meta-analysis |
| Systematic review |
Systematic review |
| Decision analysis |
Decision analysis |
| Cost-effectiveness analysis |
Cost-effectiveness analysis |
| |
| Class R: |
Consensus statement |
Low |
| Consensus report |
Low |
| Narrative review |
Low |
| Guideline |
Guideline |
| |
| Class X: |
Medical opinion |
Low |
| |
| Class Not Assignable |
Reference |
Evidence Definitions:
High Quality Evidence = Further research is very unlikely to change confidence in the estimate of effect.
Moderate Quality Evidence = Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.
Low Quality Evidence = Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate or any estimate of effect is very uncertain.
In addition to evidence that is graded and used to formulate recommendations, additional pieces of literature will be used to inform the reader of other topics of interest. This literature is not given an evidence grade and is instead identified as a Reference throughout the document.
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Identifying Information and Availability
Bibliographic Source(s)
| Trangle M, Dieperink B, Gabert T, Haight B, Lindvall B, Mitchell J, Novak H, Rich D, Rossmiller D, Setterlund L, Somers K. Major depression in adults in primary care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2012 May. 119 p. [320 references] |
Adaptation
Not applicable: The guideline was not adapted from another source.
Date Released
1996 Jan (revised 2012 May)
Guideline Developer(s)
Institute for Clinical Systems Improvement - Nonprofit Organization
Guideline Developer Comment
Organizations participating in the Institute for Clinical Systems Improvement (ICSI): Affiliated Community Medical Centers; Allina Medical Clinic; Aspen Medical Group; Baldwin Area Medical Center; Brown Clinic; Center for Diagnostic Imaging/Medical Scanning Consultants; CentraCare; Chippewa County – Montevideo Hospital & Clinic; Cuyuna Regional Medical Center; Entira Family Clinics; Essentia Health; Fairview Health Services; Family Practice Medical Center; Gillette Children's Specialty Healthcare; Grand Itasca Clinic and Hospital; Hamm Clinic; HealthEast Care System; HealthPartners Central Minnesota Clinics; HealthPartners Medical Group & Regions Hospital; Hennepin County Medical Center; Howard Young Medical Center; Hudson Physicians; Hutchinson Area Health Care; Hutchinson Medical Center; Integrity Health Network; Lake Region Healthcare Corporation; Lakeview Clinic; Mankato Clinic; MAPS Medical Pain Clinics; Marshfield Clinic; Mayo Clinic; Mercy Hospital and Health Care Center; Midwest Spine Institute; Minnesota Association of Community Health Centers; Minnesota Gastroenterology; Multicare Associates; New Richmond Clinic; North Central Heart Institute; North Clinic; North Memorial Health Care; Northwest Family Physicians; Obstetrics and Gynecology Specialists; Olmsted Medical Center; Park Nicollet Health Services; Planned Parenthood Minnesota, North Dakota, South Dakota; Quello Clinic; Rice Memorial Hospital; Ridgeview Medical Center; River Falls Medical Clinic; Riverwood Healthcare Center; South Lake Pediatrics; Southside Community Health Services; Stillwater Medical Group; University of Minnesota Physicians; Winona Health
ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060 ; fax, (952) 858-9675; e-mail: icsi.info@icsi.org; Web site: www.icsi.org .
Source(s) of Funding
The Institute for Clinical Systems Improvement's (ICSI's) work is funded by the annual dues of the member medical groups and five sponsoring health plans in Minnesota and Wisconsin.
Guideline Committee
Committee on Evidence-Based Medicine
Composition of Group That Authored the Guideline
Work Group Members: Michael Trangle, MD (Work Group Leader) (HealthPartners/Medical Group and Regions Hospital) (Psychiatry); David Rossmiller, MD (Family HealthServices Minnesota) (Family Medicine); Bob Haight, PharmD, BCPP (Fairview Health Services) (Pharmacy); Deb Rich, PhD (Fairview Health Services) (Psychology); Benita Dieperink, MD (Hennepin County Medical Center) (Psychiatry); Tom Gabert (Marshfield Clinic) (Family Medicine); Jay Mitchell, MD (Mayo Clinic) (Family Medicine); Kristin Somers, MD (Mayo Clinic) (Psychiatry); Heidi Novak, WHNP (North Point Health & Wellness Center) (Women's Health OB/GYN); Linda Setterlund, MA, CPHQ (Institute for Clinical Systems Improvement) (Clinical Systems Improvement Facilitator); Britta Lindvall, MHA (Institute for Clinical Systems Improvement) (Project Manager)
Financial Disclosures/Conflicts of Interest
Disclosure of Potential Conflicts of Interest
Benita Dieperink, MD, Work Group Member
Job Title(s), Department, Affiliated Organization: Psychiatry, HCMC, Hennepin Women's Mental Health Clinic
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: University of Minnesota lecturer, $300; Stock holdings with Pfizer and Shering-Plough both <$1,500
Thomas Gabert, MD, MPH, Work Group Member
Job Title(s), Department, Affiliated Organization: Regional Medical Director, QI Care Management, Internal Medicine, Marshfield Clinic
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Bob Haight, PharmD, BCPP, Work Group Member
Job Title(s), Department, Affiliated Organization: Psychiatric Clinical Specialist, Pharmacy, Fairview Health Services
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Jay Mitchell, MD, Work Group Member
Job Title(s), Department, Affiliated Organization: Consultant, Family Medicine, Mayo Clinic
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Heidi Novak, WHNP, Work Group Member
Job Title(s), Department, Affiliated Organization: Women's Health Nurse Practitioner, Women's Health OB/GYN, Minnesota Association of Community Health Centers
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Deborah Rich, PhD, Work Group Member
Job Title(s), Department, Affiliated Organization: Coordinator, Fairview Perinatal Loss Services and Perinatal Mood Disorders, Psychology, Fairview Health Services
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
David Rossmiller, MD, Work Group Member
Job Title(s), Department, Affiliated Organization: Family Medicine, Family Health Services Minnesota
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Kristin Somers, MD, Work Group Member
Job Title(s), Department, Affiliated Organization: Consultant in Psychiatry, Psychiatry, Mayo Clinic
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: Honorarium paid to Mayo for speaking at IPMA conference
Michael Trangle, MD, Work Group Leader
Job Title(s), Department, Affiliated Organization: Associate Medical Director, Psychiatry, HealthPartners Medical Group and Regions Hospital
National, Regional, Local Committee Affiliations: Board of Governors for DHS State Operated Services, Board of Directors for Mental Health Resources, Board of Directors for the Mental Health Association of MN
Guideline-Related Activities: DIAMOND committee, RARE Mental Health Committee
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: Institute for Clinical Systems Improvement (ICSI). Major depression in adults in primary care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2011 May. 106 p. [373 references]
Availability of Companion Documents
The following is available:
Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675; Web site: www.icsi.org ; e-mail: icsi.info@icsi.org.
In addition, several checklists and questionnaires, including the Patient Health Questionnaire (PHQ-9), the Hamilton Rating Scale for Depression (HAM-D), the Cornell Scale for Depression in Dementia, the Geriatric Depression Scale, and others, are available in the appendices to the original guideline document .
NGC Status
This summary was completed by ECRI on April 30, 1999. The information was verified by the guideline developer as of April 30, 1999. This summary was updated on December 4, 2002. The updated information was verified by the guideline developer on December 24, 2002. This summary was updated again on August 17, 2004. This summary was updated by ECRI on August 15, 2005, following the U.S. Food and Drug Administration advisory on antidepressant medications. This summary was updated by ECRI on October 3, 2005, following the U.S. Food and Drug Administration advisory on Paxil (paroxetine). This summary was updated by ECRI on December 12, 2005, following the U.S. Food and Drug Administration advisory on Paroxetine HCL - Paxil and generic paroxetine. This summary was updated by ECRI on June 13, 2006. This summary was updated by ECRI on November 22, 2006, following the FDA advisory on Effexor (venlafaxine HCl). This NGC summary was updated by ECRI Institute on July 6, 2007. The updated information was verified by the guideline developer on September 13, 2007. This summary was updated by ECRI Institute on November 9, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This summary was updated by ECRI Institute on January 10, 2008, following the U.S. Food and Drug Administration advisory on Carbamazepine. This summary was updated by ECRI Institute on July 18, 2008. This summary was updated by ECRI Institute on May 1, 2009 following the U.S. Food and Drug Administration advisory on antiepileptic drugs. This NGC summary was updated by ECRI Institute on December 22, 2009 and November 10, 2010. This summary was updated by ECRI Institute on May 20, 2011 following the U.S. Food and Drug Administration advisory on antipsychotic drugs. This NGC summary was updated by ECRI Institute on September 21, 2011. This summary was updated by ECRI Institute on April 16, 2012 following the updated U.S. Food and Drug Administration advisory on Celexa (citalopram hydrobromide). This NGC summary was updated by ECRI Institute on August 3, 2012.
Copyright Statement
This NGC summary (abstracted Institute for Clinical Systems Improvement [ICSI] Guideline) is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
The abstracted ICSI Guidelines contained in this Web site may be downloaded by any individual or organization. If the abstracted ICSI Guidelines are downloaded by an individual, the individual may not distribute copies to third parties.
If the abstracted ICSI Guidelines are downloaded by an organization, copies may be distributed to the organization's employees but may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Improvement, Inc.
All other copyright rights in the abstracted ICSI Guidelines are reserved by the Institute for Clinical Systems Improvement, Inc. The Institute for Clinical Systems Improvement, Inc. assumes no liability for any adaptations or revisions or modifications made to the abstracts of the ICSI Guidelines.
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