Childhood Adversity, Genetic Polymorphisms and Stress in First Onset Major Depression

This study is currently recruiting participants.
Verified December 2012 by Centre for Addiction and Mental Health
Sponsor:
Collaborator:
Queen's University
Information provided by (Responsible Party):
Kate Harkness, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00517764
First received: August 15, 2007
Last updated: December 11, 2012
Last verified: December 2012

August 15, 2007
December 11, 2012
December 2006
June 2013   (final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression (HRDS) [ Time Frame: every 2-3 weeks ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Depression (HRDS)
  • Beck Depression Inventory (BDI)
Complete list of historical versions of study NCT00517764 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Childhood Adversity, Genetic Polymorphisms and Stress in First Onset Major Depression
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
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:
  • Lexapro
  • Cipralex
  • S-citalopram
  • No Intervention: Healthy control
    Healthy matched control, no intervention
  • Active Comparator: Escitalopram
    Depressed subjects receiving escitalopram
    Intervention: Drug: escitalopram
  • No Intervention: subjects with major depression
    Depressed subjects not receiving study treatment, but taking part in study measures.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
224
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current diagnosis of non-psychotic unipolar major depression; first onset
  • Between 16 and 29 years of age
  • Free of antidepressant treatment for a minimum of two weeks prior to treatment OR on an inadequate antidepressant treatment
  • Minimum 8th grade education and fluency in reading English
  • Live in the Kingston Area; willing to travel to the Queen's University for appointments

Exclusion Criteria:

  • Diagnosis of previous episode(s) of major depression
  • Past or present diagnosis of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia, Substance Dependence Disorder, Borderline Personality Disorder, Anti-social Personality Disorder, or Organic Brain Syndrome
  • Electroconvulsive Therapy in the past 6 months
  • Concurrent serious medical illness judged to be contributing to the depression or impacting on treatment
  • Presence of significant suicidal ideation
Both
16 Years to 29 Years
Yes
Contact: Kate L. Harkness, PhD 613-533-2886 harkness@queensu.ca
Canada
 
NCT00517764
155/2006
No
Kate Harkness, Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Queen's University
Principal Investigator: Kate L Harkness, PhD Queens University
Principal Investigator: R.Michael Bagby, Ph.D. Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP