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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00097032
Enrollment
30
Registered
2004-11-18
Start date
2004-10-31
Completion date
2005-05-31
Last updated
2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorder, risperidone, quetiapine, sedation, cognition

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, 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.

Interventions

DRUGrisperidone; quetiapine

Sponsors

Janssen, LP
CollaboratorINDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation

Secondary

MeasureTime frame
To assess the association between subjective experience of sedation and cognitive function

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026