Clinical Trial: 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
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Stab
Brief Summary: 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.
Detailed Summary:
Several treatments are available for the treatment of acute manic and mixed episodes associated with bipolar disorder. Some of these treatments, including lithium, divalproex sodium, and carbamazepine, have been used for many years. More recently, risperidone and a number of atypical antipsychotics (olanzapine, quetiapine, ziprasidone, aripiprazole) have been approved for use in the treatment of acute mania. Paliperidone has similar properties to risperidone and is thus expected to have at least similar efficacy to risperidone in the treatment of acute manic and mixed episodes associated with bipolar disorder. Paliperidone ER has been shown to be effective in treating schizophrenia, and has an improved delivery system (with delivery at a relatively controlled rate over 24 hours) and a reduced potential for drug-drug interactions. Treatment of bipolar mania often involves more than a single medication. Studies of mood stabilizers in combination with antipsychotic agents have suggested greater efficacy or more rapid onset of action with these combinations than with any of these agents alone. It is therefore of interest to evaluate the effectiveness of paliperidone ER in combination with mood stabilizers for the treatment of acute manic and mixed episodes associated with bipolar disorder.
This randomized (patients are randomly assigned to receive paliperidone ER or placebo), double-blind (neither the patient nor the physician knows whether drug or placebo and what dosage is being taken), placebo-controlled, parallel-group, multicenter study will evaluate paliperidone ER compared with placebo over a 6-week period in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode and are taking lithium or valproate. A flexible dosing regimen will be used in this study to afford investigators the ability to adjust the dosage of each subject to achieve rapi
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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.
Original Secondary Outcome: Same as current
Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Dates:
Date Received: March 31, 2006
Date Started: April 2006
Date Completion:
Last Updated: May 17, 2011
Last Verified: March 2010
