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risperidone; quetiapine

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: May 24, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

risperidone; quetiapine · 1 trial · 1 indication

Phase 3 1
NCT00097032Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I OutpatientsBipolar Disorder
COMPLETED30 Analytics
PHASE3COMPLETED
Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

To assess the association between subjective experience of sedation and cognitive function
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Interventions

NameTypeDescription
risperidone; quetiapineDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo

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/bre...

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