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An interventional, multi-center, randomized, double-blind, placebo-controlled, active reference, flexible dose study of brexpiprazole in adults with acute schizophrenia

Published online by Cambridge University Press:  23 March 2020

S.R. Marder ,
M. Hakala ,
M. Gislum ,
A. Skuban ,
E. Weiller  and
C. Weiss
S.R. Marder
Affiliation:
Desert Pacific Mental Illness Research, Education and Clinical Center, Semel Institute for Neuroscience at UCLA, Department of Psychiatry and Biobehavioral Sciences, Los Angeles, USA
M. Hakala*
Affiliation:
Lundbeck A/S, ICR Psychiatry, DK, Valby, Denmark
M. Gislum
Affiliation:
H. Lundbeck A/S, Department of Biostatistics, Valby, Denmark
A. Skuban
Affiliation:
Otsuka Pharmaceutical Commercialization and Development Inc., Global Clinical Development, Princeton, USA
E. Weiller
Affiliation:
H. Lundbeck A/S, Medical Affairs, Valby, Denmark
C. Weiss
Affiliation:
Otsuka Pharmaceutical Commercialization and Development Inc., Global Medical Affairs, Princeton, USA
*
* Corresponding author.

Abstract

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Introduction

Brexpiprazole is a serotonin-dopamine activity modulator that is a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.

Objectives

Evaluating the efficacy, safety, and tolerability of flexible doses of brexpiprazole compared with placebo in patients with acute schizophrenia.

Aim

Primary endpoint was change from baseline to week 6 in PANSS total score and key secondary endpoint was change from baseline to week 6 in CGI-S score.

Methods

Phase 3, multi-center, randomized, double-blind, placebo-controlled, active reference, trial (NCT01810380). Hospitalized patients were randomized to brexpiprazole (2 to 4 mg/day), placebo, or quetiapine extended release (400 to 800 mg/day) for 6 weeks. Quetiapine was included as an active reference. Changes from baseline were analyzed using an MMRM approach.

Results

Mean change in PANSS total score was −20.0 and −15.9 in the brexpiprazole (n = 150) and placebo (n = 159) groups, respectively (P = 0.056). Sensitivity analyses suggested treatment effect (e.g., ANCOVA, LOCF: P = 0.025; ANCOVA, OC: P = 0.026). Mean change in PANSS total score (−24.0) with quetiapine (n = 150) was significantly greater than that with placebo (P < 0.001), demonstrating sensitivity of the assay. Brexpiprazole separated from placebo on the mean change in CGI-S score (−1.2 vs. −0.9, P = 0.014). The proportion of patients reporting TEAEs were similar between the brexpiprazole and placebo treatment groups (54% versus 54.7%).

Conclusion

Treatment with brexpiprazole showed a clinically meaningful improvement in patients with acute schizophrenia. While the difference between brexpiprazole and placebo only approached statistical significance, sensitivity analyses and secondary endpoints supported a treatment effect of brexpiprazole.

Disclosure of interest

The authors have not supplied their declaration of competing interest.

Type
FC71
Information
European Psychiatry , Volume 33 , Issue S1: Abstracts of the 24th European Congress of Psychiatry , March 2016 , pp. S99
Copyright
Copyright © European Psychiatric Association 2016
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