Depression Clinical Trial
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)
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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