Treatments for Depression: Drug Versus Psychotherapy
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|ClinicalTrials.gov Identifier: NCT00043550|
Recruitment Status : Completed
First Posted : August 12, 2002
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Supportive Expressive Therapy Drug: Sertraline Drug: Pill Placebo Drug: Venlafaxine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
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
Participants will receive sertraline.
Other Name: ZoloftDrug: Venlafaxine
Participants will receive venlafaxine.
Other Name: Effexor
Active Comparator: 2 Supportive Expressive Therapy
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: 3 Pill Placebo
Participants receive placebo.
Drug: Pill Placebo
Participants will receive a pill placebo.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043550
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jacques Barber, PhD||University of Pennsylvania|