Treatments for Depression: Drug Versus Psychotherapy

University of Pennsylvania

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Drug: Pill Placebo; Behavioral: Supportive Expressive Therapy; Drug: Sertraline; Drug: Venlafaxine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00043550

DSIR 83-ATAS

R01MH061410 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major Depressive Disorder diagnosis

Exclusion criteria

• Psychotic or bipolar disorder diagnosis
• Substance dependence in the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 3 patient groups, including a placebo group

1 Sertraline/Venlafaxine

Experimental group

Description:

Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8

Treatment:

Drug: Venlafaxine

Drug: Sertraline

2 Supportive Expressive Therapy

Active Comparator group

Description:

Participants will receive supportive-expressive psychotherapy.

Treatment:

Behavioral: Supportive Expressive Therapy

3 Pill Placebo

Placebo Comparator group

Description:

Participants receive placebo.

Treatment:

Drug: Pill Placebo