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risperidone; quetiapine

Phase 3

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

risperidone; quetiapine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2004

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

risperidone; quetiapine clinical trials

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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Frequently asked questions about risperidone; quetiapine

What is risperidone used for?

Risperidone is an antipsychotic small molecule studied in bipolar disorder. It has been evaluated in a Phase 3 trial of stable bipolar I outpatients, where cognition was measured in relation to sedative effects. Johnson & Johnson is the developer associated with this program.

What is quetiapine used for?

Quetiapine is an antipsychotic small molecule studied in bipolar disorder. It was compared with risperidone in a Phase 3 trial of stable bipolar I outpatients, focused on cognitive differences linked to sedative effects. Johnson & Johnson is the developer associated with this program.

Who makes risperidone and quetiapine?

Johnson & Johnson, which trades under the ticker JNJ, is the developer associated with the risperidone and quetiapine program in bipolar disorder. The company sponsored the Phase 3 trial that compared the two drugs in stable bipolar I outpatients.

What phase is risperidone and quetiapine in?

Risperidone and quetiapine have been studied in a Phase 3 trial in bipolar disorder. That trial is completed, and no active trials for this program are listed. The drugs are investigational in this context and are not described as FDA approved for this use.

What clinical trials are risperidone and quetiapine in?

The risperidone and quetiapine program includes one completed Phase 3 trial, NCT00097032, titled Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients. It enrolled 30 participants aged 18 years and older and used a randomized, double-blind design.