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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00177294 |
Purpose
This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Escitalopram Behavioral: Interpersonal Psychotherapy Drug: Clinical Monitoring |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Geriatric Depression: Getting Better, Getting Well |
| Estimated Enrollment: | 320 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants who are partial responders to escitalopram in first 6 weeks of treatment and receive 16 weeks of extension therapy with escitalopram 20 mg, plus interpersonal psychotherapy (IPT)
|
Drug: Escitalopram
Participants will take 10 mg escitalopram for first 6 weeks and, if inadequate response to treatment, will be randomized to 20 mg escitalopram for 16 additional weeks.
Behavioral: Interpersonal Psychotherapy
IPT includes 16 sessions of psychotherapy used to reduce lingering symptoms of depression and to decrease the burden of these symptoms.
|
|
2: Active Comparator
Participants who receive 16 weeks of extension therapy with escitalopram 20 mg plus medication clinical monitoring with no psychotherapy
|
Drug: Escitalopram
Participants will take 10 mg escitalopram for first 6 weeks and, if inadequate response to treatment, will be randomized to 20 mg escitalopram for 16 additional weeks.
Drug: Clinical Monitoring
Participants will receive 16 weeks of standard clinical monitoring. No psychotherapy will be provided.
|
The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks.
Because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00178035
http://clinicaltrials.gov/show/NCT00178074
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Charles F. Reynolds III, MD | University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience |
More Information
| Responsible Party: | University of Pittsburgh ( Charles F. Reynolds III, MD ) |
| Study ID Numbers: | R01 MH037869-01, 0404007, DATR A4-GPS |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00177294 History of Changes |
| Health Authority: | United States: Federal Government |
|
Elderly Response Escitalopram Interpersonal Psychotherapy |
Psychotherapy Caregiving Late-Life |
|
Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Depressive Disorder Cholinergic Agents Serotonin Uptake Inhibitors Citalopram Serotonin |
Behavioral Symptoms Muscarinic Antagonists Mental Disorders Mood Disorders Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Mental Disorders Therapeutic Uses Dexetimide Antidepressive Agents, Second-Generation |
Antidepressive Agents Depression Depressive Disorder Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Serotonin Agents Autonomic Agents Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents |
