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Longitudinal Study of People Presenting for First Treatment of a Mood Disorder

This study is currently recruiting participants.
Verified June 2005 by McMaster University
Sponsor:
Collaborators:
Ontario Mental Health Foundation
Canadian Institutes of Health Research (CIHR)
AstraZeneca
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01529905
First received: February 7, 2012
Last updated: February 8, 2012
Last verified: June 2005
History of Changes
  Purpose

The goal of this project is to study the course and outcome of illness in individuals who present with a first episode of depression or mania, or who have a recurrent disorder but have never received treatment. We plan to examine psychological, physical, social and environmental factors that may affect long-term outcome in these disorders


Condition
Major Depression
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Individuals Presenting With a First Treated Episode of Depression of Mania (First Episode Project)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Estimated Enrollment: 200
Study Start Date: June 1999
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients who present to a tertiary care clinic for first treatment of depression or mania

Criteria

Inclusion Criteria:

  • Primary Mood Disorder,
  • Age 16-50
  • No previous treatment with psychotropic medication (may have had a max. of 5 days treatment with antidepressants/mood stabilizer &/or they may have Haldol &/or Lorazepam for clear restraint)

Exclusion Criteria:

  • History of CNS illness (except migraines),
  • Thyroid Disease,
  • Neoplastic illness
  • History of, or currently being treated for, Anorexia or Bulimia
  • History of Traumatic Brain Injury
  • Current treatment of Attention-Deficit Hyperactivity Disorder (ADHD)
  • Previous diagnosis of OCD or primary Anxiety disorder
  • Axis-II diagnosis that would suggest non-responsiveness to pharmacotherapy.
  • Substance dependence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529905

Contacts
Contact: Helen Begin, RN 905-522-1155 ext 5409 hbegin@stjosham.on.ca

Locations
Canada, Ontario
St. Joseph's Healthcare, Centre for Mountain Health Services Recruiting
Hamilton, Ontario, Canada, L8N 3K7
Contact: Helen Begin, RN     905-522-1155 ext 5426     hbegin@stjosham.on.ca    
Sponsors and Collaborators
McMaster University
Ontario Mental Health Foundation
Canadian Institutes of Health Research (CIHR)
AstraZeneca
Investigators
Principal Investigator: Glenda MacQueen, MD, PhD McMaster University
  More Information

Publications:

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01529905     History of Changes
Other Study ID Numbers: 99-1715
Study First Received: February 7, 2012
Last Updated: February 8, 2012
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
depression
mania
bipolar
outcome
cognitive

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
 Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013