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

This study has been completed.
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: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Depression
Drug: escitalopram

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HRDS) [ Time Frame: every 2-3 weeks ] [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: December 2006
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Healthy control
Healthy matched control, no intervention
Active Comparator: Escitalopram
Depressed subjects receiving escitalopram
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: subjects with major depression
Depressed subjects not receiving study treatment, but taking part in study measures.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517764

Locations
Canada, Ontario
Queens University
Kingston, Ontario, Canada, K7L 3N6
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Queen's University
Investigators
Principal Investigator: Kate L Harkness, PhD Queens University
Principal Investigator: R.Michael Bagby, Ph.D. Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Kate Harkness, Research Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00517764     History of Changes
Other Study ID Numbers: 155/2006
Study First Received: August 15, 2007
Last Updated: August 6, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
major depressive disorder
MDD
escitalopram
open-label
major depression
serotonin transporter
brain-derived neurotrophic factor

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014