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Treatments for Depression: Drug Versus Psychotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marna S. Barrett, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00043550
First received: August 9, 2002
Last updated: June 12, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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
Criteria

Inclusion criteria:

  • Major Depressive Disorder diagnosis

Exclusion criteria:

  • Psychotic or bipolar disorder diagnosis
  • Substance dependence in the last 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pennsylvania
Investigators
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
Mental Disorders
Mood Disorders
Serotonin Uptake Inhibitors
Sertraline
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014