A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder

Summary

The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.

Timeline

Start

2006-04

Primary completion

2007-09

Completion

2007-11

Outcome

Met primary endpoint

paper Paliperidone ER was superior to placebo at the 3-week endpoint {primary outcome; PMID 20565430 ↗

paper primary outcome; least-squares mean difference in change from baseline in YMRS scores [95% confidence interval (CI): -5.5 (-7.57; -3.35); p < 0.001} PMID 20565430 ↗

Publications

• Vieta E, Nuamah IF, Lim P, Yuen EC, Palumbo JM, Hough DW, Berwaerts J. A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder. Bipolar Disord. 2010 May;12(3):230-43. doi: 10.1111/j.1399-5618.2010.00815.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paliperidone	Unknown	3 mg	—
Subject	Paliperidone	Unknown	12 mg	—
Comparator	Quetiapine	Small molecule	400 mg	—
Comparator	Quetiapine	Small molecule	800 mg	—

Indications