Conditions: Bipolar Disorder Alcohol Abuse
Keywords: Adolescents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Quetiapine and Placebo arm 2: Quetiapine and Topiramate

Interventions: intervention 1: quetiapine and placebo intervention 2: Quetiapine and Topiramate
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: