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Sponsors and Collaborators: |
Mood Disorders Center of Ottawa AstraZeneca |
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Information provided by: | Mood Disorders Center of Ottawa |
ClinicalTrials.gov Identifier: | NCT00252226 |
This is a single center, open prospective study to evaluate the effectiveness of quetiapine monotherapy in the maintenance treatment of adolescent patients with a bipolar spectrum disorder (bipolar I and bipolar II disorders, cyclothymia, and bipolar disorder not otherwise specified [bipolar NOS]) for a minimum of 48 weeks. Patients will be screened (enrolment phase) either when already stabilized or during an acute episode of mania/hypomania or depression.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: Quetiapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders: An Open Prospective Longitudinal Study of the Effectiveness of Quetiapine Monotherapy in Preventing Relapse and Minimizing Neurocognitive Dysfunction Among Adolescents Manifesting Bipolar Spectrum Disorders |
Estimated Enrollment: | 100 |
Study Start Date: | June 2004 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Mood Disorders Center of Ottawa | |
Ottawa, Ontario, Canada, K1G 4G3 |
Principal Investigator: | Paul Grof, M.D. | Mood Disorders Center of Ottawa |
Principal Investigator: | Anne Duffy, M.D. | Mood Disorders Center of Ottawa |
Responsible Party: | MDCO ( Paul Grof ) |
Study ID Numbers: | D1441L00024 |
Study First Received: | November 9, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00252226 |
Health Authority: | Canada: Health Canada |
Quetiapine bipolar spectrum disorders |
Quetiapine Affective Disorders, Psychotic Mental Disorders |
Bipolar Disorder Mood Disorders Psychotic Disorders |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |