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Patient Dimensions as Predictors of Varied Treatment Responses and Outcomes in Patients With Major Depression

This study has been completed.
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00744406
First received: August 28, 2008
Last updated: August 29, 2008
Last verified: August 2008
History of Changes
  Purpose

Depression affects over one million people in Canada, resulting in $14.4 billion per year in costs to Canadian society. In order to prevent this often lifelong disorder, it is critically important to identify risk factors for the recurrence of depression. A crucial force in maintaining depression is the generation of stressful life events. That is, individuals who have a history of depression are likely to generate the very events that precipitate future depressive episodes (e.g., relationship break-up, fired from job, conflicts with the law) due to negative personality characteristics and disrupted social support networks resulting from previous episodes. This project is the first to test a model that examines the role of negative personality, low social support, and childhood abuse and neglect as risk factors for the generation of stressful life events that predict future depression. We will test this model in a group of patients meeting formal criteria for depression who will be treated and then followed up for 12 months or until depression recurrence. With this long-term design we will be in a unique position to understand how depression is maintained over time, thus suggesting important treatment strategies to prevent depression recurrence.


Condition Intervention Phase
Depression
Major Depressive Disorder
 Behavioral: Cognitive Behavioral Therapy
Behavioral: Interpersonal Therapy
Drug: Antidepressant medication (sertraline ,paroxetineor or venlafaxine)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Dimensions as Predictors of Response, Relapse and Recurrence Following Cognitive-Behavioral Therapy, Interpersonal Psychotherapy and Pharmacotherapy Treatment of Patients With Major Depression.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: intermittent ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: July 2003
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Cognitive Behavioral Therapy
All patients randomized to this condition will receive 16 consecutive weeks of manualized cognitive-behaviour therapy provided by either M.S.W or Ph.D. psychotherapists trained and certified in CBT. Treatment will be conducted according to the manualized CBT treatment for depression outlined by Beck and colleagues (Beck et al., 1979), and consistent with the protocol administered in the NIMH study.
Experimental: 2 Behavioral: Interpersonal Therapy
All patients randomized to this condition will receive 16 consecutive weeks of manualized interpersonal psychotherapy conducted by M.S.W., Ph.D., or M.Ed. psychotherapists trained and certified in IPT.
Experimental: 3 Drug: Antidepressant medication (sertraline ,paroxetineor or venlafaxine)
Patients patients randomized to this condition will be treated for 16 weeks with different classes of anti-depressant medications, using standardized protocols. Patients will receive 16 weeks of treatment with either a SSRI (sertraline or paroxetine) or a SNRI (venlafaxine). The dose range is as follows: sertraline 50-200 mg/day, paroxetine 20-40 mg/day, venlafaxine 75-375 mg/day. Patients unable to continue with the prescribed medication due to side effects and/or lack of response will be prescribed an alternate medication during the first two weeks of the protocol.

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  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet the criteria for DSM-IV diagnosis of non-psychotic, major depression based on the Structured Interview for DSM-IV, Axis I disorders
  • Score > 16 the 17-item Hamilton Rating Scale for Depression
  • Ages between 18 and 60
  • Are medication-free (i.e., of antidepressants) for a minimum of two weeks prior to treatment are eligible for entry into treatment protocols
  • Minimum eight grade education and fluency in reading English
  • Ability to give informed consent and complete assessment instruments unassisted

Exclusion Criteria:

  • a SCID-I diagnosis of:

    • Bipolar Disorder (past or present),
    • Schizoaffective Disorder,
    • Schizophrenia,
    • Substance Abuse Disorder (current or within the past 6 months),
    • Borderline or Antisocial Personality Disorder,
    • Organic Brain Syndrome
  • Electroconvulsive Therapy (ECT) within the past 6 months
  • Concurrent active medical illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744406

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Mental Health Foundation
Investigators
Principal Investigator: R. Michael Bagby, PhD Centre for Addiction and Mental Health
  More Information

No publications provided

Responsible Party: R. Michael Bagby, PhD, Cantre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00744406     History of Changes
Other Study ID Numbers: 160/2001
Study First Received: August 28, 2008
Last Updated: August 29, 2008
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
recurrent depression
major depressive disorder
interpersonal therapy
cognitive behavioral therapy
 antidepressant treatment
outcome predictors
personality dimensions

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Sertraline
Venlafaxine
Psychotropic Drugs
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 16, 2013