Bipolar Disorder Clinical Trial
Official title:
Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Out-Patients.
The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.
To compare the treatment effects of risperidone and quetiapine on cognitive function, using
measures commonly believed to be affected by sedation and at doses typically used in
clinical settings in stable bipolar I outpatients.One-half of patients are randomized to
treatment sequence risperidone-quetiapine (R-Q), and the other one-half to
quetiapine-risperidone (Q-R). Patients randomized to R-Q receive 2 mg of risperidone with
dinner the night before testing and placebo with breakfast on the day of testing. After a 6
- 14 day washout period they receive 100 mg quetiapine with dinner the night before their
second day of testing and 100 mg with breakfast the day of testing.
Those randomized to Q-R receive the same treatments, but in reverse order. Patients
randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and
placebo with breakfast on the day of testing. After a 6-14 day washout period they receive
100 mg quetiapine with dinner the night before their second day of testing and 100 mg with
breakfast the day of testing. Those randomized to Q-R receive the same treatments, but in
reverse order.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind
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