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Treatments for Depression: Drug Versus Psychotherapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Mental Health (NIMH).   Recruitment status was  Active, not recruiting

First Received on August 9, 2002.   Last Updated on September 19, 2008   History of Changes
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: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Hamilton Ratings for Depression [ Time Frame: Measured twice a week for the first 4 weeks, then once a week for the remaining 12 weeks, and again after the first 16 weeks ] [ Designated as safety issue: No ]

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
Experimental: 1 Sertraline
Participants receive sertraline.
Drug: Sertraline
Participants will receive sertraline.
Other Name: Zoloft
Experimental: 2 Venlafaxine
Participants will receive venlafaxine.
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 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
Criteria

Inclusion criteria:

  • Major Depressive Disorder diagnosis

Exclusion criteria:

  • Psychotic or bipolar disorder diagnosis
  • Substance dependence in the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043550

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Marna Barrett, University of Pennsylvannia
ClinicalTrials.gov Identifier: NCT00043550     History of Changes
Other Study ID Numbers: R01 MH61410, DSIR 83-ATAS
Study First Received: August 9, 2002
Last Updated: September 19, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
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 February 09, 2012