Treatments for Depression: Drug Versus Psychotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Supportive Expressive Therapy
* Drug: Sertraline
* Drug: Pill Placebo
* Drug: Venlafaxine


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Sertraline/Venlafaxine<br>Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8 | Drug: Sertraline<br>* Participants will receive sertraline.<br>* Other names: Zoloft;Drug: Venlafaxine<br>* Participants will receive venlafaxine.<br>* Other names: Effexor;|
| Active Comparator: 2 Supportive Expressive Therapy<br>Participants will receive supportive-expressive psychotherapy. | Behavioral: Supportive Expressive Therapy<br>* The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.<br>|
| Placebo Comparator: 3 Pill Placebo<br>Participants receive placebo. | Drug: Pill Placebo<br>* Participants will receive a pill placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression-17 Item | 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. | symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder