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The efficacy and safety of 12 weeks of treatment with sertindole or olanzapine in patients with chronic schizophrenia who did not respond successfully to their previous treatments: a randomized, double-blind, parallel-group, flexible-dose study

Kwon, Jun Sooa,b; Mittoux, Auréliad; Hwang, Jae Yeona,c; Ong, Adelinee; Cai, Zhuo-Jif; Su, Tung-Pingg

International Clinical Psychopharmacology: November 2012 - Volume 27 - Issue 6 - p 326–335
doi: 10.1097/YIC.0b013e32835767a0
Original Articles

The aim of this study was to evaluate the efficacy, safety, and tolerability of sertindole in comparison with olanzapine in patients with chronic schizophrenia who did not respond successfully to their previous treatments. Patients with schizophrenia who were at least moderately ill and had failed to respond to previous antipsychotic treatment were randomized to double-blind sertindole or olanzapine treatment. A total of 389 patients were treated, 196 with sertindole (mean dose=17 mg/day) and 193 with olanzapine (mean dose=16 mg/day). Both drugs improved all the efficacy scale scores including the Positive and Negative Syndrome Scale total score. Although sertindole failed to prove noninferiority to olanzapine in terms of reduction in PANSS total score with the last-observation-carried-forward analysis, this can be attributed to the higher withdrawal rate in the sertindole group by day 16 by which sertindole was up-titrated to the effective dose. On excluding early withdrawals, the noninferiority criterion was fulfilled, as also in the observed-case analysis. They had similar safety profiles with respect to the total incidence of adverse events. The incidence of asymptomatic QT prolongation was higher in the sertindole group. Sertindole has an efficacy and safety profile that is comparable to that of olanzapine. The slow titration schedule and lack of sedating effect of sertindole should be considered when initiating treatment with this drug.

aDepartment of Neuropsychiatry, Seoul National University Hospital

bInstitute of Human Behavioral Medicine, Seoul National University College of Medicine

cDepartment of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea

dH. Lundbeck A/S, Copenhagen, Denmark

eLundbeck Singapore Pte. Ltd, Singapore, Singapore

fBeijing Anding Hospital, Capital University of Medical Sciences, Beijing, China

gDepartment of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan

Trial registration: a clinicaltrials.gov identifier: NCT00864045.This work was previously presented the 10th Biennial Meeting of the Asia-Pacific Society for Neurochemistry, Phuket, Thailand, 17–20 October 2010.

Correspondence to Jun Soo Kwon, MD, PhD, Department of Neuropsychiatry, Seoul National University Hospital, Seoul, Republic of Korea Tel: +82 2 2072 2972; fax: +82 2 744 7241; e-mail: kwonjs@snu.ac.kr

Received February 9, 2012

Accepted June 25, 2012

© 2012 Lippincott Williams & Wilkins, Inc.