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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097032
• Other study ID #: CR004654
• Secondary ID: RIS-OUT-184
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2004
• Last updated: May 20, 2011
• Start date: October 2004
• Est. completion date: May 2005

Study information

• Verified date: March 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• risperidone; quetiapine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Janssen, LP

References & Publications (1)

Harvey PD, Hassman H, Mao L, Gharabawi GM, Mahmoud RA, Engelhart LM. Cognitive functioning and acute sedative effects of risperidone and quetiapine in patients with stable bipolar I disorder: a randomized, double-blind, crossover study. J Clin Psychiatry. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation
Secondary	To assess the association between subjective experience of sedation and cognitive function

External Links

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