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Treatments for Depression: Drug Versus Psychotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043550
First Posted: August 12, 2002
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
August 9, 2002
August 12, 2002
August 26, 2015
June 2, 2017
June 2, 2017
November 2001
June 2009   (Final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression-17 Item [ Time Frame: symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16 ]
Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.
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Complete list of historical versions of study NCT00043550 on ClinicalTrials.gov Archive Site
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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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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/Venlafaxine
    Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8
    Interventions:
    • Drug: Sertraline
    • Drug: Venlafaxine
  • Active Comparator: 2 Supportive Expressive Therapy
    Participants will receive supportive-expressive psychotherapy.
    Intervention: Behavioral: Supportive Expressive Therapy
  • Placebo Comparator: 3 Pill 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00043550
R01MH061410( U.S. NIH Grant/Contract )
R01MH061410 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
Yes
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University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Jacques Barber, PhD University of Pennsylvania
University of Pennsylvania
April 2017

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