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Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Alcohol Use in Adolescents & Young Adults
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.
Details
| Lead sponsor | University of Cincinnati |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 56 |
| Start date | 2008-04 |
| Completion | 2010-06 |
Conditions
- Bipolar Disorder
- Alcohol Abuse
Interventions
- quetiapine and placebo
- Quetiapine and Topiramate
Primary outcomes
- Drinks Per Day — baseline to 12 weeks or endpoint (up to 11 weeks)
Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period). - Drinks Per Drinking Day — baseline to 12 weeks or endpoint (up to 11 weeks)
Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period) - Percentage of Days Abstinent — baseline to 12 weeks or endpoint (up to 11 weeks)
Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period). - Percent Heavy Drinking Days — baseline to 12 weeks or endpoint (up to 11 weeks)
Change in percent heavy drinking days (number of days of \> 4 drinks/day divided by number of days in that study period).
Countries
United States