We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder.
- Authors
Vieta, Eduard; Nuamah, Isaac F; Lim, Pilar; Yuen, Eric C; Palumbo, Joseph M; Hough, David W; Berwaerts, Joris
- Abstract
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: 12: 230–243. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S. Objectives: To evaluate the antimanic efficacy and safety of paliperidone extended-release (ER) tablets in patients with bipolar I disorder. Methods: This study included a 3-week, double-blind, acute treatment phase (paliperidone ER versus placebo, with quetiapine as control), and a 9-week, double-blind, maintenance phase (paliperidone ER versus quetiapine). Patients [n = 493; Young Mania Rating Scale (YMRS) score ≥ 20] were randomized (2:2:1) to flexibly dosed paliperidone ER (3–12 mg/day), quetiapine (400–800 mg/day), or placebo for the acute treatment phase. During the maintenance phase, patients assigned to placebo were switched to paliperidone ER but not included in analysis of efficacy. Results: Paliperidone ER was superior to placebo at the 3-week endpoint {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} and noninferior to quetiapine at the 12-week endpoint [least-squares mean difference (95% CI): 1.7 (−0.47; 3.96)]. The median mode dose during the 12-week treatment period was 9 mg for paliperidone ER and 600 mg for quetiapine. The most common (≥ 10%) treatment-emergent adverse events during the 12-week period were: headache (16%), somnolence (10%), and akathisia (10%) for paliperidone ER; somnolence (21%), sedation and dry mouth (17% each), headache (14%), and dizziness (13%) for quetiapine. Body weight increase ≥ 7% from baseline to 12-week endpoint was 8% with paliperidone ER and 17% with quetiapine. A higher percentage of paliperidone ER (13.9%) versus quetiapine patients (7.5%) ‘switched to depression’ at the12-week endpoint. Conclusions: Paliperidone ER (3–12 mg/day) was efficacious and tolerable in the treatment of acute mania.
- Subjects
BIPOLAR disorder; THERAPEUTICS; PSYCHOSES; AFFECTIVE disorders; PLACEBOS; NEUROLOGIC manifestations of general diseases
- Publication
Bipolar Disorders, 2010, Vol 12, Issue 3, p230
- ISSN
1398-5647
- Publication type
Article
- DOI
10.1111/j.1399-5618.2010.00815.x