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Treatments for Depression: Drug vs. Psychotherapy



Treatments for Depression: Drug vs. Psychotherapy

For Condition: Depression
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Major Depressive Disorder diagnosis Exclusion criteria: - Psychotic or bipolar disorder diagnosis - Substance dependence in the last 6 months
Total Enrollment: 180

Location and Contact Information:

University of Pennsylvania *Recruiting*
Philadelphia,  Pennsylvania,  19104
United States
Recruiting Kim  Marin 215-662-2552


Additional Information:
Study ID Numbers:  61410-01A1; 
Study Start Date: November 2001
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043550

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