The efficacy and safety of flexible dose ranges of risperidone vs. Placebo or divalproex sodium in the treatment of manic or mixed episodes associated with bipolar 1 disorder
NCT Number
Not Available
Primary Citation
Not Yet Available
Data Specification
Annotated CRF
Available upon data request approval
Trial Information
Generic Name
Risperidone
Product Name
RISPERDAL®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
39
% Female
N/A
% White
N/A
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
RIS-USA-240
Data Partner
Johnson & Johnson
Condition Studied
Bipolar Disorder
Mean/Median Age (Years)
N/A
Supporting Documentation
Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
APPROVED DATA REQUESTS ASSOCIATED WITH THIS TRIAL
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