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

NCT ID: NCT00517764

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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major depressive disorder MDD escitalopram open-label major depression serotonin transporter brain-derived neurotrophic factor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy control

Healthy matched control, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Escitalopram

Depressed subjects receiving escitalopram

Group Type ACTIVE_COMPARATOR

escitalopram

Intervention Type DRUG

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.

subjects with major depression

Depressed subjects not receiving study treatment, but taking part in study measures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lexapro Cipralex S-citalopram

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen's University

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Kate Harkness

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kate L Harkness, PhD

Role: PRINCIPAL_INVESTIGATOR

Queens University

R.Michael Bagby, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Queens University

Kingston, Ontario, Canada

Site Status

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://www.camh.net/research

Information about research at the Centre for Addiction and Mental Health

Other Identifiers

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155/2006

Identifier Type: -

Identifier Source: org_study_id