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

This study has been completed.

Sponsors and Collaborators: Centre for Addiction and Mental Health
Ontario Mental Health Foundation
Information provided by: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00744406
  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 II

MedlinePlus related topics:   Antidepressants    Depression    Mental Health   

Drug Information available for:   Sertraline hydrochloride    Sertraline    Paroxetine    Paroxetine hydrochloride    Paroxetine Mesylate    Venlafaxine    Venlafaxine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment
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.

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
1: Experimental 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.
2: Experimental 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.
3: Experimental 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.

Show detailed description  Show Detailed Description

  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


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

Study placed in the following topic categories:
Depression
Mental Disorders
Venlafaxine
Mood Disorders
Sertraline
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin
Recurrence
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on October 24, 2008




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