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Treatments for Depression: Drug Versus Psychotherapy

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
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
History of Changes

August 9, 2002
June 12, 2012
November 2001
June 2009   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00043550 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Treatments for Depression: Drug Versus Psychotherapy
Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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.
  • Drug: Sertraline
    Participants will receive sertraline.
    Other Name: Zoloft
  • Drug: Pill Placebo
    Participants will receive a pill placebo.
  • Drug: Venlafaxine
    Participants will receive venlafaxine.
    Other Name: Effexor
  • Experimental: 1 Sertraline
    Participants receive sertraline.
    Intervention: Drug: Sertraline
  • Experimental: 2 Venlafaxine
    Participants will receive venlafaxine if they do not respond to sertraline by week 8
    Intervention: Drug: Venlafaxine
  • Experimental: 3 Supportive-expressive psychotherapy
    Participants will receive supportive-expressive psychotherapy.
    Intervention: Behavioral: Supportive Expressive Therapy
  • Placebo Comparator: 4 Placebo
    Participants receive placebo.
    Intervention: Drug: Pill Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Major Depressive Disorder diagnosis

Exclusion criteria:

  • Psychotic or bipolar disorder diagnosis
  • Substance dependence in the last 6 months
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043550
R01 MH61410, R01MH061410, DSIR 83-ATAS
Yes
Marna S. Barrett, PhD, University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Jacques Barber, PhD University of Pennsylvania
University of Pennsylvania
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP