Expired Study
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Philadelphia, Pennsylvania 19104


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.


Study summary:

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.


Criteria:

Inclusion criteria: - Major Depressive Disorder diagnosis Exclusion criteria: - Psychotic or bipolar disorder diagnosis - Substance dependence in the last 6 months


Study is Available At:


Original ID:

R01 MH61410


NCT ID:

NCT00043550


Secondary ID:

R01MH061410


Study Acronym:


Brief Title:

Treatments for Depression: Drug Versus Psychotherapy


Official Title:

Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pennsylvania


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

156


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jacques Barber, PhD
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:November 2001
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 12, 2012
First Received Date:August 9, 2002

Study Outcomes

Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Supportive Expressive Therapy
Description:The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
Arm Name:3 Supportive-expressive psychotherapy
Intervention Type:Drug
Name:Sertraline
Description:Participants will receive sertraline.
Arm Name:1 Sertraline
Other Name:Zoloft
Intervention Type:Drug
Name:Pill Placebo
Description:Participants will receive a pill placebo.
Arm Name:4 Placebo
Intervention Type:Drug
Name:Venlafaxine
Description:Participants will receive venlafaxine.
Arm Name:2 Venlafaxine
Other Name:Effexor

Study Arms

Study Arm Type:Experimental
Arm Name:1 Sertraline
Description:Participants receive sertraline.
Study Arm Type:Experimental
Arm Name:2 Venlafaxine
Description:Participants will receive venlafaxine if they do not respond to sertraline by week 8
Study Arm Type:Experimental
Arm Name:3 Supportive-expressive psychotherapy
Description:Participants will receive supportive-expressive psychotherapy.
Study Arm Type:Placebo Comparator
Arm Name:4 Placebo
Description:Participants receive placebo.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pennsylvania
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Barber JP, Muenz LR. The role of avoidance and obsessiveness in matching patients to cognitive and interpersonal psychotherapy: empirical findings from the treatment for depression collaborative research program. J Consult Clin Psychol. 1996 Oct;64(5):951-8.
PMID:8916624

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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