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Metabolic and body mass parameters after treatment with JNJ-37822681, a novel fast-dissociating D2 receptor antagonist, vs olanzapine in patients with schizophrenia

Ella J. Daly, MB, MRCPsych

Janssen Research & Development, LLC, Raritan, NJ, USA

Justine M. Kent, MD

Janssen Research & Development, LLC, Raritan, NJ, USA

Luc Janssens, MSc

Janssen Research & Development, a division of Janssen Pharmaceutica NV, Beerse, Belgium

John W. Newcomer, MD

Department of Psychiatry and Behavioral Sciences, University of Miami Leonard M. Miller School of Medicine, Miami, FL, USA

Gitta Hüsken, PhD

Janssen-Cilag BV, Tilburg, Netherlands

Peter De Boer, PhD

Janssen Research & Development, a division of Janssen Pharmaceutica NV, Beerse, Belgium

Luc Tritsmans, MD

Janssen Research & Development, a division of Janssen Pharmaceutica NV, Beerse, Belgium

Mark E. Schmidt, MD

Janssen Research & Development, a division of Janssen Pharmaceutica NV, Beerse, Belgium

BACKGROUND: The highly selective and fast dissociating D2 receptor antagonist JNJ-37822681 may be associated with lower risk for weight gain and undesirable metabolic effects compared with available antipsychotics.

METHODS: In this double-blind, randomized study, patients were randomly assigned (1:1:1:1:1) to 12 weeks of JNJ-37822681 (10 mg, 20 mg, or 30 mg, twice daily) or olanzapine (10 mg/d during week 1; 15 mg/d after week 1), or 6 weeks of placebo (followed by 6 weeks of olanzapine, 15 mg/d). Metabolic and body mass parameters were assessed at weeks 6 and 12.

RESULTS: For metabolic parameters, at week 6 none of the JNJ-37822681 groups demonstrated significant change vs placebo; however, significant changes (P < .05) were observed in the olanzapine vs placebo group in triglycerides, low-density lipoprotein (LDL) and very-LDL cholesterol, and free fatty acids. For all JNJ-37822681 groups, mean weight changes at week 12 (-0.3 [10 mg], + 0.3 [20 mg], + 0.8 kg [30 mg]) were significantly less (P < .001) than for the olanzapine group (+ 2.7 kg). A higher percentage of overweight or obese patients (baseline body mass index: ≥25 kg/m2) receiving olanzapine had ≥7% increase in weight than those receiving JNJ-37822681 (9.8% vs 2.3%, respectively).

CONCLUSIONS: JNJ-37822681 treatment was associated with a more favorable outcome on weight and metabolic adverse effects vs olanzapine for treating schizophrenia; the 10 mg twice-daily dose demonstrated minimal to no weight gain.

KEYWORDS: antipsychotic, body mass index, dopamine receptor antagonist, JNJ-37822681, metabolic parameters, schizophrenia

ANNALS OF CLINICAL PSYCHIATRY 2013;25(3):173-183

CORRESPONDENCE: Ella J. Daly, MB, MRCPsych 1125 Trenton-Harbourton Road PO Box 200 Titusville, NJ 08560 USA E-MAIL: edaly2@its.jnj.com
Annals of Clinical Psychiatry ©2013 Frontline Medical Communications Inc.

 
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