Bipolar Disorder Clinical Trial
Official title:
Longitudinal Study of Individuals Presenting With a First Treated Episode of Depression of Mania (First Episode Project)
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
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2014 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 50 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare, Centre for Mountain Health Services | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | AstraZeneca, Canadian Institutes of Health Research (CIHR), Ontario Mental Health Foundation |
Canada,
Judd LL, Akiskal HS, Maser JD, Zeller PJ, Endicott J, Coryell W, Paulus MP, Kunovac JL, Leon AC, Mueller TI, Rice JA, Keller MB. A prospective 12-year study of subsyndromal and syndromal depressive symptoms in unipolar major depressive disorders. Arch Gen Psychiatry. 1998 Aug;55(8):694-700. — View Citation
Mueller TI, Keller MB, Leon AC, Solomon DA, Shea MT, Coryell W, Endicott J. Recovery after 5 years of unremitting major depressive disorder. Arch Gen Psychiatry. 1996 Sep;53(9):794-9. — View Citation
Solomon DA, Keller MB, Leon AC, Mueller TI, Shea MT, Warshaw M, Maser JD, Coryell W, Endicott J. Recovery from major depression. A 10-year prospective follow-up across multiple episodes. Arch Gen Psychiatry. 1997 Nov;54(11):1001-6. — View Citation
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