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Treatments for Depression: Drug Versus Psychotherapy

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Supportive Expressive Therapy (Behavioral); Sertraline (Drug); Pill Placebo (Drug); Venlafaxine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Jacques Barber, PhD, Principal Investigator, Affiliation: University of Pennsylvania

Summary

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.

Clinical Details

Official title: Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hamilton Ratings for Depression

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Major Depressive Disorder diagnosis

Exclusion criteria:

- Psychotic or bipolar disorder diagnosis

- Substance dependence in the last 6 months

Locations and Contacts

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: November 2001
Last updated: June 12, 2012

Page last updated: August 23, 2015

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