|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mood Disorders Center of Ottawa |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | Mood Disorders Center of Ottawa |
| ClinicalTrials.gov Identifier: | NCT00252226 |
Purpose
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 |
|---|---|---|
|
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) |
Eligibility| Ages Eligible for Study: | 12 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | MDCO ( Paul Grof ) |
| Study ID Numbers: | D1441L00024 |
| Study First Received: | November 9, 2005 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00252226 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Quetiapine bipolar spectrum disorders |
|
Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions |
Affective Disorders, Psychotic Quetiapine Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents |