Childhood Adversity, Genetic Polymorphisms and Stress in First Onset Major Depression
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| First Received Date ICMJE | August 15, 2007 | ||||||||
| Last Updated Date | December 11, 2012 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hamilton Rating Scale for Depression (HRDS) [ Time Frame: every 2-3 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00517764 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Childhood Adversity, Genetic Polymorphisms and Stress in First Onset Major Depression | ||||||||
| Official Title ICMJE | The Role of Childhood Adversity and Genetic Polymorphisms in the Serotonin and Brain-Derived Neurotrophic Factor Systems in the Sensitization to Stress in First-Onset Major Depression (Blue Sky Project) | ||||||||
| Brief Summary | The Blue Sky Project, a 5-year study funded by the Canadian Institutes of Health Research, seeks to examine how genetics and early life experiences work together to cause a person's very first onset of depression by increasing sensitivity to stress. |
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| Detailed Description | Many forms of stress can precipitate an episode of depression. However, not everyone who experiences these sorts of stressors becomes depressed. Individuals with an at-risk genetic profile are more likely to get depressed in the face of stress, and require less severe levels of stress to get depressed, than individuals without this genetic profile. This model can help explain why young people get depressed the very first time. Young people with a particular variant of the serotonin transporter gene might require less severe levels of stress in both childhood and adulthood to precipitate their first episode of depression than individuals who do not possess this at-risk genetic variant. The current study involves 3 arms: Participants at the Centre for Addiction and Mental Health site were enrolled in a 16-week trial of escitalopram (Lexapro/Cipralex), an established SSRI antidepressant that has been shown to be more effective and tolerable than other SSRIs. A psychiatrist and a trained research assistant will meet with participants every 2-3 weeks for the duration of the 16-week trial and participants will be asked to complete a number of standard psychological tests. After completion of the treatment phase, participants may continue into the follow-up phase involving monthly telephone contact and short appointments over an 18-month period. This arm of the study has finished and is no longer recruiting participants. Participant at the Sunnybrook Health Sciences Centre site were enrolled in an assessment-only non-treatment arm. A research assistant met with participants to complete the same standard psychological tests as above. Participants received standard medical care from their attending psychiatrist. Participants may continue into the follow-up phase involving short appointments over an 18-month period to complete psychological assessments. This arm of the study has finished and is no longer recruiting participants. Participant at the Queen's University site are enrolled in an assessment-only non-treatment arm. A research assistant will meet with participants to complete the same standard psychological tests as above. Participants will receive standard medical care from their attending psychiatrist or will be referred for treatment if they do not currently have a psychiatrist. Participants may continue into the follow-up phase involving short appointments over an 18-month period to complete psychological assessments. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE | Drug: escitalopram
Patients started on 20mg of escitalopram and this dose was increased based on tolerability and therapeutic response to a maximum dose of 40mg by week 12. The trial was 16 weeks. The treatment trial has completed and is no longer accepting patients.
Other Names:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 224 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years to 29 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00517764 | ||||||||
| Other Study ID Numbers ICMJE | 155/2006 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Kate Harkness, Centre for Addiction and Mental Health | ||||||||
| Study Sponsor ICMJE | Centre for Addiction and Mental Health | ||||||||
| Collaborators ICMJE | Queen's University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre for Addiction and Mental Health | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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