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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen, LP
• Treatments: Hypnotics and Sedatives; Quetiapine Fumarate; Risperidone

Criteria

Inclusion Criteria:

• Subjects with bipolar I disorder in partial or full remission and deemed clinically stable

Exclusion Criteria:

• Current use of benzodiazepines, prescription or herbal sleep agents

• Use of antihistamines

• Use of antipsychotic medications in the past 6 months

• Pregnant/breastfeeding females

• Females not using contraception

• Illicit drug users