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.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: risperidone  Drug: quetiapine	Phase IV

Further Study Details: 

Primary Outcomes: To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation
Secondary Outcomes: To compare the treatment effects on the subjective experience of sedation; To assess the association between subjective experience of sedation and cognitive function
Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Both

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

New Jersey
      CNS Research Institute, Clementon,  New Jersey,  08021,  United States; Recruiting

Study ID Numbers:  RIS-OUT-184
Record last reviewed:  November 2004
Last Updated:  November 17, 2004
Record first received:  November 17, 2004
ClinicalTrials.gov Identifier:  NCT00097032
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08