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

NCT00744406 | Completed Phase 2

• 1 other identifier: 160/2001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Major Depressive Disorder

Keywords

recurrent depression; major depressive disorder; interpersonal therapy; cognitive behavioral therapy; antidepressant treatment; outcome predictors; personality dimensions

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

  intermittent

Study Arms (3)

1

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy

2

EXPERIMENTAL

Behavioral: Interpersonal Therapy

3

EXPERIMENTAL

Drug: Antidepressant medication (sertraline ,paroxetineor or venlafaxine)

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

1

Interpersonal Therapy BEHAVIORAL

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.

2

Antidepressant medication (sertraline ,paroxetineor or venlafaxine) DRUG

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.

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Mental Health Foundation: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Antidepressive Agents; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• R. Michael Bagby, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: September 1, 2008
• Study Start: July 1, 2003
• Primary Completion: September 1, 2006
• Last Updated: September 1, 2008

Record last verified: 2008-08

Locations

CA (1)