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.
Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in adolescents with bipolar disorder. Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to greater reduction in alcohol consumption (number of drinks per day, number of drinks per drinking day, and number of heavy drinking days) and greater abstinence (percentage of days abstinent) compared with quetiapine alone. Specific Aim 2: To obtain preliminary data regarding the efficacy of topiramate for reducing manic symptoms in adolescents with co-occurring alcohol use and bipolar disorders. Hypothesis 2: We hypothesize that the topiramate in combination with quetiapine will produce greater reduction in Young Mania Rating Scale (YMRS) scores than quetiapine alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1 Dosing Schedule and Titration of Topiramate: All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner. Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.
Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1 Dosing Schedule and Titration of Topiramate: All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner. Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Drinks Per Day
Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Drinks Per Drinking Day
Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Percentage of Days Abstinent
Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Percent Heavy Drinking Days
Change in percent heavy drinking days (number of days of \> 4 drinks/day divided by number of days in that study period).
Time frame: baseline to 12 weeks or endpoint (up to 11 weeks)
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