Recruiting
Phase 3

Antidepressive Medication with Psychotherapy

Sponsor:

Sir Mortimer B. Davis - Jewish General Hospital

Code:

NCT00220623

Conditions

Major Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

antidepressant medications, flexible drug choice

CBT, Psychodynamic or Supportive Psychotherapy

Study Details

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

Study ID

NCT00220623

Start date

Aug, 2004

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

antidepressant medications, flexible drug choice

CBT, Psychodynamic or Supportive Psychotherapy

Primary outcome measure

  • Time to recovery of major depressive episode [ Time Frame: undefined ]
  • Time to recurrence of major depression, once recovered [ Time Frame: undefined ]
  • improvement in depressive defenses [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Joan Oppenheimer, B.A.

514 340-8222

Locations

Institute of Community and Family Psychiatry

Recruiting

Montreal, Quebec, Canada, H3T 1E4

Contacts

Joan Oppenheimer, B.A.

514 340 -8222

Lisa SM Barbagallo, BS

514 340-8222

Principal Investigator:

John C. Perry, M.P.H., M.D.

More Information

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Last update posted

Sep 22, 2005

Last verified

Sep, 2005

Keywords

  • major depression
  • psychotherapy
  • antidepressant medications
  • clincial trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital on 2005-09-22.