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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00021528 |
STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated
Condition | Intervention | Phase |
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Depression |
Drug: citalopram Drug: BuproprionSR Drug: buspirone Drug: Lithium Drug: mirtazapine Drug: nortriptyline Drug: sertraline Drug: tranylcypromine Drug: VenlafaxineXR Behavioral: Cognitive Therapy Drug: T3 (Triiodothyronine) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sequenced Treatment Alternatives to Relieve Depression |
Estimated Enrollment: | 4000 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | September 2006 |
The STAR*D project will enroll 4,000 outpatients (ages 18 -75) diagnosed with nonpsychotic Major Depressive Disorder. Participants will be initially treated (open label) with citalopram, the Level 1 treatment, for a minimum of 8 weeks. Patients who experience minimal benefit will be strongly encouraged to complete 12 weeks of treatment in order to maximize the chances of symptom remission (unless no benefit at all is seen after 8 weeks). All participants will also receive a brief depression educational program.
At each level change, participants will be asked to indicate the unacceptability of the potential treatment strategies (e.g, to augment or to switch medications). Participants will then be eligible for random assignment to one of the acceptable and medically safe treatment options.
Level 2: Participants who either did not have an adequate response to or could not tolerate citalopram are eligible for Level 2. The Level 2 treatment strategies are:
i) Medication and Psychotherapy Switch: switch to sertraline, venlafaxineXR, bupropionSR, or cognitive therapy (CT).
ii) Medication and Psychotherapy Augmentation: add to citalopram either a) buspirone, b) bupropionSR, or c) CT.
iii) Medication Only Switch or Medication Only Augmentation options are available for participants for whom CT is unacceptable.
iv)Psychotherapy Only Switch or Psychotherapy Only Augmentation options are available for participants for whom additional medication is unacceptable at this point in the study (participants must be willing to continue citalopram)
Level 2A: Participants without a satisfactory response to their Level 2 treatment are eligible for random assignment to additional treatment at Level 2A (if medically safe and acceptable). Level 2A is included so that all participants entering Level 3 have had an opportunity to respond to at least 2 medications. Level 2A consists of Medication Switch to one of two antidepressant medications (venlafaxineXR or bupropion SR).
Level 3: Participants without satisfactory response to Level 2 and,if appropriate Level 2A, are eligible for random assignment to one of the following treatments (if acceptable and medically safe):
i) Medication Switch to: a) mirtazapine or b) nortriptyline, a tricyclic antidepressant.
ii) Medication Augmentation: Add (to current Level 2 or Level 2A medication) either: a) lithium or b) thyroid hormone (T3).
Level 4: Participants without an adequate response to Level 3 are eligible for random assignment to Level 4 treatment (if acceptable and medically safe). Level 4 includes two Medication Switch options: to tranylcypromine [a monoamine oxidase inhibitor (MAOI)], or to mirtazapine plus venlafaxineXR.
After Level 4, participants without an adequate response will discuss other acceptable treatment options with their physician.
Once an adequate response is achieved at Levels 2, 2A, 3 or 4, participants are eligible to enter the 12-month follow-up, during which time they will remain on their current treatment(s) and will be asked about their symptoms and other relevant information monthly by telephone. ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
- Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD score 14 or greater)
Study Director: | A. John Rush, MD | University of Texas Southwestern Medical Center Department of Psychiatry |
Study ID Numbers: | N01 MH90003, DSIR AT |
Study First Received: | July 20, 2001 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00021528 |
Health Authority: | United States: Federal Government |
Sequential Treatment Major Depression Treatment Resistant Depression |
Depression Lithium Carbonate Depressive Disorder, Major Mirtazapine Depressive Disorder Tranylcypromine Citalopram Serotonin Histamine |
Behavioral Symptoms Buspirone Mental Disorders Nortriptyline Mood Disorders Histamine phosphate Sertraline Dexetimide Lithium |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Monoamine Oxidase Inhibitors Antidepressive Agents, Second-Generation Antidepressive Agents Tranquilizing Agents Central Nervous System Depressants |
Histamine Agents Enzyme Inhibitors Adrenergic alpha-Antagonists Serotonin Uptake Inhibitors Pharmacologic Actions Antidepressive Agents, Tricyclic Serotonin Agents Histamine Antagonists Histamine H1 Antagonists Anti-Anxiety Agents Adrenergic Antagonists Central Nervous System Agents |