Citation

Vieta E, Nuamah IF, Lim P, Yuen EC, Palumbo JM, Hough DW, Berwaerts J. Bipolar Disord. 2010; 12(3): 230-243.

Copyright

(Copyright © 2010, John Wiley and Sons)

DOI

10.1111/j.1399-5618.2010.00815.x

PMID

unavailable

Abstract

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. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S.

Language: en

Keywords

Humans; Adult; Female; Male; Middle Aged; adult; human; classification; suicide; female; male; Psychiatric Status Rating Scales; aged; Treatment Outcome; bipolar disorder; Double-Blind Method; insomnia; suicidal ideation; depression; randomized controlled trial; scoring system; Follow-Up Studies; major depression; clinical trial; treatment outcome; Mania; fatigue; article; controlled study; neuroleptic agent; prolactin blood level; functional assessment; sedation; tachycardia; xerostomia; priority journal; controlled clinical trial; double blind procedure; quetiapine; somnolence; middle aged; constipation; diazepam; drug safety; placebo; Bipolar Disorder; follow up; patient compliance; drug efficacy; extrapyramidal symptom; tardive dyskinesia; diarrhea; drug tolerability; nausea; tremor; extrapyramidal syndrome; hypersalivation; drug withdrawal; multicenter study; akathisia; lorazepam; antihistaminic agent; mania; muscle hypertonia; bipolar I disorder; side effect; cholinergic receptor blocking agent; maintenance therapy; agitation; controlled release formulation; myalgia; clonazepam; electrocardiogram; body weight; remission; Bipolar I disorder; Quetiapine; psychological rating scale; tooth pain; dyspepsia; Antipsychotic Agents; dizziness; increased appetite; lethargy; Dibenzothiazepines; Montgomery Asberg Depression Rating Scale; drug induced headache; drug dose increase; drug dose titration; treatment duration; mixed mania and depression; Clinical Global Impression scale; vital sign; rebound; Positive and Negative Syndrome Scale; tablet formulation; Pyrimidines; pulse rate; Young Mania Rating Scale; pyrimidine derivative; dibenzothiazepine derivative; muscle spasm; drug delivery system; Drug Delivery Systems; paliperidone; Isoxazoles; isoxazole derivative; acute mania; extended release tablet; Global Assessment of Functioning score; Paliperidone ER