A Randomized, Double-Blind, Placebo-Controlled Study of 2 Dose Ranges of Paliperidone Extended-Release in the Treatment of Subjects With Schizoaffective Disorder
J Clin Psychiatry 2010;71(5):587-598
© Copyright 2015 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
Objective: This study was designed to assess efficacy and safety of paliperidone extended-release (ER) in patients with schizoaffective disorder.
Method: A randomized, 6-week, double-blind, placebo-controlled study was conducted. Subjects with a Structured Clinical Interview for DSM-IV diagnosis of schizoaffective disorder, Positive and Negative Syndrome Scale (PANSS) total score ≥ 60, score ≥ 4 on ≥ 2 PANSS items (hostility, excitement, tension, uncooperativeness, poor impulse control), and Young Mania Rating Scale and/or Hamilton Depression Rating Scale, 21-item version scores ≥ 16 were eligible. Subjects received higher-dose (12 mg/d) or lower-dose (6 mg/d) paliperidone ER. Dose adjustments by 3-mg increments were allowed until day 15. The study was conducted from October 2006 through February 2008.
Results: A total of 316 subjects were randomly assigned to paliperidone ER lower dose (n = 109), higher dose (n = 100), or placebo (n = 107). Mean ± SD modal dose in lower- and higher-dose groups: 5.7 ± 0.9 and 11.6 ± 1.0 mg/d, respectively. Mean ± SE PANSS total score (primary outcome) improved significantly with higher-dose paliperidone ER versus placebo (–32.4 ± 2.1 versus –24.1 ± 2.1; P = .003). Change with lower-dose paliperidone ER (–27.7 ± 2.1) was not significantly different from placebo (P = .187). No new safety issues were identified; common adverse events were headache (placebo: 16.8%; paliperidone ER: lower dose, 13.9%, higher dose, 13.3%) and tremor (3.7%, 12.0%, 11.2%, respectively). Mean prolactin and weight changes were greater with active treatment than placebo.
Conclusions: Higher-dose paliperidone ER was effective and well tolerated in patients with acute schizoaffective disorder. These findings and those from a companion study constitute the first registration program for antipsychotic treatment in schizoaffective disorder.
Trial Registration: clincaltrials.gov Identifier: NCT00397033
J Clin Psychiatry 2010;71(5):587–598
Submitted: July 28, 2009; accepted February 11, 2010.
Corresponding author: Carla M. Canuso, MD, Johnson & Johnson Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd–E12604, Titusville, NJ 08560 (email@example.com).