NCT00097032

Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients

Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Out-Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	risperidone; quetiapine

Timeline

• Start date: 2004-10-01
• Completion: 2005-05-01
• First posted: 2004-11-18
• Last updated: 2011-05-24