Status:
COMPLETED
Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen, LP
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief 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, judg...
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 st...
Eligibility Criteria
Inclusion
- Subjects with bipolar I disorder in partial or full remission and deemed clinically stable
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00097032
Start Date
October 1 2004
End Date
May 1 2005
Last Update
May 24 2011
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