Treatments for Depression: Drug Versus Psychotherapy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression |
- Hamilton Ratings for Depression [ Time Frame: Measured at week, 2,4,6,7, 8,12,15 and 16 and then once a month ] [ Designated as safety issue: No ]
| Enrollment: | 156 |
| Study Start Date: | November 2001 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 Sertraline
Participants receive sertraline.
|
Drug: Sertraline
Participants will receive sertraline.
Other Name: Zoloft
|
|
Experimental: 2 Venlafaxine
Participants will receive venlafaxine if they do not respond to sertraline by week 8
|
Drug: Venlafaxine
Participants will receive venlafaxine.
Other Name: Effexor
|
|
Experimental: 3 Supportive-expressive psychotherapy
Participants will receive supportive-expressive psychotherapy.
|
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.
|
|
Placebo Comparator: 4 Placebo
Participants receive placebo.
|
Drug: Pill Placebo
Participants will receive a pill placebo.
|
Detailed Description:
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 seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. 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:
- Major Depressive Disorder diagnosis
Exclusion criteria:
- Psychotic or bipolar disorder diagnosis
- Substance dependence in the last 6 months
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Jacques Barber, PhD | University of Pennsylvania |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marna S. Barrett, PhD, Research Projects Director, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00043550 History of Changes |
| Other Study ID Numbers: | R01 MH61410, R01MH061410, DSIR 83-ATAS |
| Study First Received: | August 9, 2002 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pennsylvania:
|
Major Depressive Disorder |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Sertraline Venlafaxine Serotonin Uptake Inhibitors Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation |
ClinicalTrials.gov processed this record on May 23, 2013