A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder

Summary

The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.

Timeline

Start

2006-05

Primary completion

2010-04

Completion

2010-04

Outcome

Met primary endpoint

paper Median time to recurrence of any mood symptoms (primary endpoint) was: 558 days (paliperidone ER), 283 days (placebo) PMID 22377512 ↗

paper Time to recurrence of any mood symptoms was significantly longer with paliperidone ER than placebo (p=0.017; PMID 22377512 ↗

Publications

• Berwaerts J, Melkote R, Nuamah I, Lim P. A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode. J Affect Disord. 2012 May;138(3):247-58. doi: 10.1016/j.jad.2012.01.047. Epub 2012 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Olanzapine	Small molecule	5 mg	Oral
Comparator	Olanzapine	Small molecule	20 mg	Oral
Subject	Paliperidone	Unknown	3 mg	Oral
Subject	Paliperidone	Unknown	12 mg	Oral

Indications