Bipolar Disorder Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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