Childhood Adversity, Genetic Polymorphisms and Stress in First Onset Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

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.
    

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.
    

Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Lexapro; Cipralex; S-citalopram
Intervention MeSH terms: Citalopram; Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depressive disorder; MDD; escitalopram; open-label; major depression; serotonin transporter; brain-derived neurotrophic factor