Depression Clinical Trial
Official title:
Stress Generation and Recurrent Depression: The Role of Differential Treatment Response
NCT number | NCT00745017 |
Other study ID # | 091/2003 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | August 28, 2008 |
Last updated | August 29, 2008 |
Start date | July 2001 |
Verified date | August 2008 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Ontario Mental Health Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Rating Scale for Depression | intermittent | No |
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