TY  - JOUR
PY  - 2010//
TI  - A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder
JO  - Bipolar disorders
A1  - Vieta, E.
A1  - Nuamah, I.F.
A1  - Lim, P.
A1  - Yuen, E.C.
A1  - Palumbo, J.M.
A1  - Hough, D.W.
A1  - Berwaerts, J.
SP  - 230
EP  - 243
VL  - 12
IS  - 3
N2  - OBJECTIVES: To evaluate the antimanic efficacy and safety of paliperidone extended-release (ER) tablets in patients with bipolar I disorder. <br><br>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. <br><br>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. <br><br>CONCLUSIONS: Paliperidone ER (3-12 mg/day) was efficacious and tolerable in the treatment of acute mania. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S.<p /> <p>Language: en</p>
LA  - en
SN  - 1398-5647
UR  - http://dx.doi.org/10.1111/j.1399-5618.2010.00815.x
ID  - ref1
ER  -