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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: | NCT00745017 |
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 |
Phase I |
MedlinePlus related topics: | Antidepressants Depression Mental Health Stress |
Drug Information available for: | Sertraline hydrochloride Sertraline Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Venlafaxine Venlafaxine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Stress Generation and Recurrent Depression: The Role of Differential Treatment Response |
Enrollment: | 72 |
Study Start Date: | July 2001 |
Primary Completion Date: | July 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.
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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.
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3: Experimental |
Drug: Antidepressant medication
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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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
a SCID-I diagnosis of:
Canada, Ontario | |||||
Centre for Addiction and Mental Health | |||||
Toronto, Ontario, Canada, M5T 1R8 |
Centre for Addiction and Mental Health |
Ontario Mental Health Foundation |
Principal Investigator: | Kate L Harkness, PhD | Queen's University |
Responsible Party: | Queen's University ( Kate Leslie Harkness, PhD ) |
Study ID Numbers: | 091/2003 |
First Received: | August 28, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00745017 |
Health Authority: | Canada: Health Canada |
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