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
Product Info
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
Disclaimer
Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.