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P0117 - Weight change on aripiprazole-clozapine combination in schizophrenic patients with weight gain and suboptimal response on clozapine: 16-week double-blind study

Published online by Cambridge University Press:  16 April 2020

W.W. Fleischhacker ,
M.E. Heikkinen ,
J.P. Olié ,
W. Landsberg ,
P. Dewaele ,
R. McQuade  and
D. Hennicken
W.W. Fleischhacker
Affiliation:
Department of Biological Psychiatry, University of Innsbruck, Innsbruck, Austria
M.E. Heikkinen
Affiliation:
Helsinki City Health Centre, Dept. of Psychiatry, Community Mental Health Services, Helsinki, Finland
J.P. Olié
Affiliation:
Hopital Saint Anne, Paris, France
W. Landsberg
Affiliation:
Bristol-Myers Squibb Company, Uxbridge, UK
P. Dewaele
Affiliation:
Bristol-Myers Squibb Company, Braine L'Alleud, Belgium
R. McQuade
Affiliation:
Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, USA
D. Hennicken
Affiliation:
Bristol-Myers Squibb Company, Braine L'Alleud, Belgium

Abstract

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Background and Aim:

Significant weight increase in schizophrenic patients can impact on compliance and is associated with long-term cardiovascular complications. This study aims to evaluate the effect on weight, overall efficacy, safety and tolerability of combining aripiprazole and clozapine in schizophrenic patients with suboptimal response to clozapine.

Methods:

This 16-week, multicentre, randomised, double-blind, placebo-controlled study included patients with schizophrenia (DSM-IV-TR) experiencing at least 2.5 kg weight gain and suboptimal efficacy and/or safety on clozapine. Patients were randomised to a combination of aripiprazole (5-15 mg/day) and clozapine or clozapine monotherapy (baseline dose maintained up to 16 weeks). Endpoints included body weight change from baseline to Week 16 (primary), PANSS, CGI-I, IAQ scales, and safety assessments (secondary).

Results:

Two hundred and seven patients were randomised (baseline mean weight = 92.4 kg [52-148.4], mean weight gain on clozapine = +14.9 kg [2.5-66], mean clozapine dose = 373.7 mg/d), and 90% and 94% completed the study for combination and monotherapy, respectively. Statistically significant reductions from baseline were observed in both mean body weight (-2.53 kg and -0.38 kg, p<0.001) and waist line (-0.00 cm and -2.00 cm, p<0.001) on combination compared with monotherapy. BMI, fasting total and LDL cholesterol, and CGI-I and IAQ significantly improved on combination. There was no change in PANSS total score. Five patients discontinued for adverse events on combination, and one patient on monotherapy.

Conclusion:

Although there was no benefit regarding psychopathological symptoms, combining aripiprazole and clozapine results in significant benefits in terms of weight, BMI and fasting cholesterol in schizophrenic patients suboptimally treated with clozapine monotherapy.

Type
Poster Session I: Schizophrenia and Psychosis
Information
European Psychiatry , Volume 23 , Issue S2: 16th AEP Congress - Abstract book - 16th AEP Congress , April 2008 , pp. S114 - S115
Copyright
Copyright © European Psychiatric Association 2008
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