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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: January 2011 - Volume 26 - Issue 1 - p 25–34
doi: 10.1097/YIC.0b013e3283400d58
Original Articles

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.

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.