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

NCT00517764 | Completed

• 1 other identifier: 155/2006
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression (HRDS)

  every 2-3 weeks

Study Arms (3)

Healthy control

NO INTERVENTION

Healthy matched control, no intervention

Escitalopram

ACTIVE COMPARATOR

Depressed subjects receiving escitalopram

Drug: escitalopram

subjects with major depression

NO INTERVENTION

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

Interventions

escitalopram 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.

Also known as: Lexapro, Cipralex, S-citalopram

Escitalopram

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Queen's University: collaborator

Study Sites (2)

Queens University

Kingston, Ontario, K7L 3N6, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kate L Harkness, PhD

  Queens University

  PRINCIPAL INVESTIGATOR

• R.Michael Bagby, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: December 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

CA (2)