A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are experiencing a manic or mixed episode while they are taking lithium or valproate. This study will also evaluate the effect of paliperidone ER compared with placebo on overall functioning, on how quickly a response is seen, on improvement in severity of illness, on health-related functional status, on depressive symptoms, and on psychotic symptoms. The relationship between blood levels and the effectiveness and safety of paliperidone ER will be evaluated, including the effect of food relative to time of taking the drug.
Affective Psychosis, Bipolar
Drug: Paliperidone ER
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- The primary effectiveness outcome is the change in total YMRS score from baseline (first dose) to the last assessment in the 6-week double-blind treatment phase.
- The secondary effectiveness outcome is the change in GAF score from baseline (first dose) to the last assessment in the 6-week double-blind treatment phase.
|Study Start Date:||April 2006|
|Study Completion Date:||August 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309686
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|