A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder.

Abstract

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 >or= 60, score >or= 4 on >or= 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 >or= 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.

• Authors: Carla M Canuso, Jean-Pierre Lindenmayer, Colette Kosik-Gonzalez, Ibrahim Turkoz, Jennifer Carothers, Cynthia A Bossie, Nina R Schooler
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 71 Issue 5 Pg. 587-98 (May 2010) ISSN: 1555-2101 [Electronic] United States
• PMID: 20492853 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: ©Copyright 2010 Physicians Postgraduate Press, Inc.

Chemical References

• Antipsychotic Agents
• Delayed-Action Preparations
• Isoxazoles
• Pyrimidines
• Paliperidone Palmitate

Topics

• Adult
• Antipsychotic Agents (administration & dosage, adverse effects, therapeutic use)
• Delayed-Action Preparations
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Isoxazoles (administration & dosage, adverse effects, therapeutic use)
• Male
• Paliperidone Palmitate
• Psychiatric Status Rating Scales
• Psychotic Disorders (drug therapy)
• Pyrimidines (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome