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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00043550 |
Purpose
This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Behavioral: Supportive Expressive Therapy Drug: Sertraline Drug: Pill Placebo Drug: Venlafaxine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression |
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2001 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1 Sertraline: Experimental
Participants receive sertraline.
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Drug: Sertraline
Participants will receive sertraline.
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2 Venlafaxine: Experimental
Participants will receive venlafaxine.
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Drug: Venlafaxine
Participants will receive venlafaxine.
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3 Supportive-expressive psychotherapy: Experimental
Participants will receive supportive-expressive psychotherapy.
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Behavioral: Supportive Expressive Therapy
The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
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4 Placebo: Placebo Comparator
Participants receive placebo.
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Drug: Pill Placebo
Participants will receive a pill placebo.
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MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo.
Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine [Effexor] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment.
Patients who are randomized to receive medication or placebo are initially evaluated on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are evaluated twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
More Information
| Responsible Party: | University of Pennsylvannia ( Marna Barrett ) |
| Study ID Numbers: | R01 MH61410, DSIR 83-ATAS |
| Study First Received: | August 9, 2002 |
| Last Updated: | September 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00043550 History of Changes |
| Health Authority: | United States: Federal Government |
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Major Depressive Disorder |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms |
Serotonin Agents Mental Disorders Therapeutic Uses Venlafaxine Mood Disorders Sertraline Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |