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NCT00309686 - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episodes Associated With Bipolar I Disorder


Data Specification

Annotated CRF

Available upon data request approval

Product Info

Generic Name
Paliperidone
Product Name
INVEGA®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
300
% Female
46.0%
% White
77.0%
Product Class
Atypical Antipsychotics
Sponsor Protocol Number
R076477-BIM-3003
Data Partner
Johnson & Johnson
Condition Studied
Bipolar Disorder
Mean/Median Age (Years)
40.0

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

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.