You could be reading the full-text of this article now if you...

If you have access to this article through your institution,
you can view this article in

Evaluation of the effect of paliperidone extended release and quetiapine on corrected QT intervals: a randomized, double-blind, placebo-controlled study

Hough, David W.a; Natarajan, Jayaa; Vandebosch, Anb; Rossenu, Stefanb; Kramer, Michellea; Eerdekens, Mariëlleb

International Clinical Psychopharmacology:
doi: 10.1097/YIC.0b013e3283400d58
Original Articles
Abstract

The effect of two atypical antipsychotics on QTc intervals (heart rate-corrected QT interval) was evaluated. Patients (N=109) with schizophrenia (79%) or schizoaffective disorder (21%) were randomly assigned in 2 : 2 : 1 ratio to paliperidone extended release (ER), quetiapine, or placebo. Doses of 12 and 18 mg/day of paliperidone ER were compared with quetiapine 800 mg/day. Least-squares mean change from baseline in population-specific linear-derived correction method from baseline to days 6–7 at individual tmax was 5.1 ms less [90% confidence interval: −9.2 to −0.9] with paliperidone ER 12 mg/day than with quetiapine 800 mg/day. On the basis of a prespecified 10-ms noninferiority margin, paliperidone ER was thus declared noninferior to quetiapine (primary analysis). Mean change in population-specific linear-derived correction method from baseline to days 11–12 at individual tmax was 2.3 ms less (90% confidence interval: −6.8 to 2.3) with paliperidone ER 18 mg/day than with quetiapine 800 mg/day. Treatment-emergent adverse events occurred in 36 (82%) patients treated with paliperidone ER, 41 (95%) patients treated with quetiapine, and 14 (64%) patients treated with placebo. No adverse events of a proarrhythmic nature were noted. The effect on the QTc interval in patients with schizophrenia or schizoaffective disorder was comparable between paliperidone ER 12 mg/day (maximum recommended dose), paliperidone ER 18 mg/day (supratherapeutic dose), and quetiapine 800 mg/day.

Author Information

aJohnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, USA

bJohnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica N.V., Beerse, Belgium

Correspondence to Marielle Eerdekens, MD, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica N.V., Turnhoutseweg 30, Beerse 2340, Belgium Tel: +32 14 60 6274; fax: +32 14 60 5089; e-mail: meerdeke@its.jnj.com

These data were presented at the Society of Biological Psychiatry (SOBP) 62nd Annual Meeting, May 19–24, San Diego, California, 2007; 160th American Psychiatric Association (APA) Annual Meeting, May 19–24, San Diego, California, 2007; 47th Annual Meeting of the National Institute of Mental Health, New Clinical Drug Evaluation Unit (NCDEU), June 14–17, Boca Raton, Florida, 2007; 59th Institute on Psychiatric Services (IPS), October 11–14, New Orleans, Louisiana, 2007; 20th Congress of the European College of Neuropsycho- pharmacology (ECNP), October 13–17, Vienna, 2007.

Received April 30, 2010

Accepted August 31, 2010

© 2011 Lippincott Williams & Wilkins, Inc.