Clinical Trial: Treatments for Depression: Drug vs. Psychotherapy

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to compare supportive expressive psychodynamic therapy to antidepressant medication plus Clinical Management for the treatment of patients with Major Depressive Disorder (MDD). A second goal is to evaluate the long-term effects of these 2 treatments on the recurrence of depression.

Condition Treatment or Intervention Phase
Depression
 Behavior: Supportive Expressive Therapy
 Drug: Sertraline
 Drug: Pill Placebo
 Drug: Venlafaxine
Phase III

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Official Title: Efficacy of Dynamic Therapy vs. Selective Serotonin Reuptake Inhibitor for Depression

Further Study Details: 

Expected Total Enrollment:  180

Study start: November 2001;  Expected completion: June 2006

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   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

  • Major Depressive Disorder diagnosis

Exclusion criteria:

  • Psychotic or bipolar disorder diagnosis
  • Substance dependence in the last 6 months

Location and Contact Information

Jacques P. Barber, PhD       barberj@mail.med.upenn.edu

Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Kim Marin, B.A.  215-662-2552    Kmarin@mail.med.upenn.edu 
Marna Barrett, Ph.D.  215-349-8094    MSB@mail.med.upenn.edu 
Jacques P Barber, Ph.D,  Principal Investigator
Moira Rynn, M.D.,  Sub-Investigator
Karl Rickels, M.D.,  Sub-Investigator

More Information

Study ID Numbers:  61410-01A1
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  August 9, 2002
ClinicalTrials.gov Identifier:  NCT00043550
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005