Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517764
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2007-08-15
Brief Title:
Childhood Adversity Genetic Polymorphisms and Stress in First Onset Major Depression
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons very first onset of depression by increasing sensitivity to stress
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 LexaproCipralex 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 Queens 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
Participants at the Centre for Addiction and Mental Health site were enrolled in a 16-week trial of escitalopram LexaproCipralex 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 Queens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None