Efficacy of 18-Months of Antidepressive Medication Plus CBT or Dynamic or Supportive Psychotherapy for Recurrent Major Depression

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Major Depressive Disorder affects approximately 16% of the adult population over the lifetime. Controlled studies indicate that short-term antidepressive medications or psychotherapy produce full remission in only about 46% of patients. Furthermore, about 80% of patients will continue to have subsequent recurrences after remission of the first episode, with each episode increasing the probability of future recurrences. This pilot study will examine whether antidepressive medications plus one of three commonly available types of psychotherapy used in the short-term treatment of depression can protect against the recurrence of depression if active treatment is extended to 18-months duration. Results will aid designing a more complete study.

Adults with an acute episode of major depressive disorder with at least one prior episode will be randomized to Antidepressive medications (ADM) plus 18-months of either Cognitive-behavioral therapy (CBT) or Dynamic psychotherapy (DYN), or to a standard control therapy, Supportive Clinical Management (SUP-CM). We will determine whether a higher percentage of those receiving either CBT or DYN remain well after three years of follow-up, compared to those receiving the standard control treatment. We will also examine the reduction in psychological risk factors as well as potential economic benefits of the three approaches.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Treatments: Antidepressive Agents

Criteria

Inclusion Criteria:

• DSM-IV major depressive episode with at least one prior MDE episode, and

• HRSD-17 score above 16 at screening and intake (one-week apart)

Exclusion Criteria:

• bipolar type I disorder

• any psychotic disorder

• serious alcohol or substance abuse disorder

• organic mental disorder

• serious suicidal intent that warrants imminent hospitalization

• first trimester pregnancy

• likelihood of moving too far away to continue treatment for 18-months