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

NCT00220623 | Unknown Phase 3

• 1 other identifier: #04-013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depression

Keywords

major depression; psychotherapy; antidepressant medications; clincial trial

Outcome Measures

Primary Outcomes (3)

• Time to recovery of major depressive episode

• Time to recurrence of major depression, once recovered

• improvement in depressive defenses

Secondary Outcomes (3)

• proportion of time with depressive symptoms

• improvement on other specified psychological measures related to depression

• cost-effectiveness measures

Interventions

antidepressant medications, flexible drug choice DRUG

CBT, Psychodynamic or Supportive Psychotherapy BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Institute of Community and Family Psychiatry

Montreal, Quebec, H3T 1E4, Canada

RECRUITING

Related Publications (1)

• Trijsburg RW, Semeniuk TT, Perry JC. An Empirical Study of the Differences in Interventions between Dynamic Psychotherapy and Cognitive-Behavioral Therapy for Recurrent Major Depression. Canadian J Psychoanalysis 12(2): 325-345, 2004.

  BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• John C Perry, M.P.H., M.D.

  S.M.B.D. - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Oppenheimer, B.A.

CONTACT

514 340-8222

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2004
• Last Updated: September 22, 2005

Record last verified: 2005-09

Locations

CA (1)