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

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.

Timeline

Start

2006-04

Primary completion

—

Completion

2007-08

Outcome

Missed primary endpoint

paper combination treatment (-14.3 [10.0]) compared with mood stabilizer monotherapy (-13.2 [10.9]; p=0.16). PMID 20947174 ↗

paper may have contributed to its failure to differentiate combination treatment from mood stabilizer monotherapy for the primary and secondary efficacy measures. PMID 20947174 ↗

Publications

• Berwaerts J, Lane R, Nuamah IF, Lim P, Remmerie B, Hough DW. Paliperidone extended-release as adjunctive therapy to lithium or valproate in the treatment of acute mania: a randomized, placebo-controlled study. J Affect Disord. 2011 Mar;129(1-3):252-60. doi: 10.1016/j.jad.2010.09.011. Epub 2010 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paliperidone	Unknown	3 mg	Oral
Subject	Paliperidone	Unknown	12 mg	Oral

Indications