Clinical Trial: A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-release Paliperidone in Subjects With Bipolar I Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multicenter Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release Paliperidone in the Treatm

Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone extended release on global functioning, and the relationship between blood levels and the effectiveness and safety of paliperidone.

Detailed Summary: Several treatments are available for the treatment of acute manic and mixed episodes associated with bipolar disorder. Some of these treatments although used for many years, are associated with well-known problems such as poor tolerability, significant toxicities, narrow therapeutic ranges, and drug interactions. Often, several drugs must be used in combination to achieve the best clinical effect. More recently, a group of compounds known as atypical antipsychotics, such as risperidone, have been licensed for use in this indication. Based on the pharmacological profile of Paliperidone, it is expected to be effective in the treatment of acute manic and mixed episodes associated with bipolar disorder. Paliperidone extended release has been shown to be effective in schizophrenia and it has an improved drug delivery system with a reduced potential for drug interactions. Study drug tablets are designed to deliver the appropriate amount of drug (3 mg or 6 mg) using a "Push-Pull" delivery system based on a patented oral osmotic pump technology (OROS) that allows the drug to be delivered at a relatively controlled rate for 24 hours. This study will test 3 different doses of paliperidone extended release (3, 6, or 12 mg/day once daily) compared to placebo (inactive substance). There are 3 parts to the study: a screening and washout phase that lasts up to 7 days to determine if patients are eligible for the study and to discontinue all current medications, a double-blind treatment phase that lasts for 3 weeks, and a follow-up phase that lasts about 1 week after the end-of-study visit or early withdrawal from the study. During the double-blind treatment phase, patients are randomly assigned to receive treatment either with placebo or 1 of 3 daily doses of paliperidone extended release. Patients assigned to paliperidone extended release will receive either 3, 6, or 12 mg/day given once daily for a 3-week period. All patients whether receiving paliperidone extended rel
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: The primary effectiveness outcome is the change in the total Young Mania Rating Scale score from baseline to the last assessment during the 3 week double-blind treatment phase.

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary effectiveness outcome is the change in Global Assessment of Functional Scale from baseline to endpoint or the last assessment during the double-blind treatment phase.

Original Secondary Outcome: Same as current

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: March 3, 2006
Date Started: February 2006
Date Completion:
Last Updated: June 2, 2011
Last Verified: June 2011