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EPA-0808 - Efficacy and Safety of Adjunctive Brexpiprazole (opc-34712) in Major Depressive Disorder (MDD): A Phase iii, Randomized, Placebo-Controlled Study

Published online by Cambridge University Press:  15 April 2020

M.E. Thase ,
M. Hobart ,
C. Augustine ,
J. Youakim ,
P. Zhang ,
N. Hefting ,
R.D. McQuade ,
W. Carson ,
M. Nyilas  and
R. Sanchez
M.E. Thase
Affiliation:
Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA
M. Hobart
Affiliation:
Clinical Management, Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, USA
C. Augustine
Affiliation:
Clinical Management, Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, USA
J. Youakim
Affiliation:
Global Clinical Development (CNS), Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
P. Zhang
Affiliation:
Biostatistics, Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, USA
N. Hefting
Affiliation:
Clinical Development ICR Psychiatry, Lundbeck A/S, Valby, Denmark
R.D. McQuade
Affiliation:
Global Medical Affairs Regulatory Affairs and Alliances, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
W. Carson
Affiliation:
OPDC Presidents/CEO's Office, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
M. Nyilas
Affiliation:
Clinical Management, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
R. Sanchez
Affiliation:
Global Clinical Development (CNS), Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA

Abstract

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Objective:

Brexpiprazole is a serotonin-noradrenaline-dopamine agent that binds with high affinity to multiple serotonin, norepinephrine and dopamine receptors. In particular, Brexpiprazole is a partial agonist at dopamine D2/D3 and 5-HT1A receptors and an antagonist at 5-HT2A and norepinephrine alpha1B receptors.

We assessed the efficacy and safety of brexpiprazole versus placebo as adjunctive therapy to anti-depressant therapy (ADT) in subjects with MDD who demonstrated inadequate response to ADT.

Methods:

This trial had 3 phases: a screening phase (7-28 days); a prospective phase (Phase A): 8-week, single-blind placebo plus an investigator-determined, open-label ADT; a randomized phase (Phase B): 6-week, double-blind, adjunctive brexpiprazole (2 mg/day) vs. placebo in patients with an inadequate response to ADT.

The primary efficacy endpoint was the change from the end of Phase A (Week 8) to the end of Phase B (Week 14) in MADRS Total Score. The key secondary endpoint was the change in mean SDS score. Other secondary endpoints were mean change in CGI-S, IDS-R, HAMD and HAMA.

Results:

Of 379 randomized patients, completion rates at Week 14 were high (92.9%). Statistically significant improvements in mean MADRS Total score were observed for subjects receiving adjunctive brexpiprazole 2mg/day compared with placebo (p=0.0001) at endpoint. In addition, on all secondary endpoints Brexpiprazole showed a statistically significant advantage over placebo.

Commonly reported adverse events in the brexpiprazole group (>5% and more than twice placebo) were weight gain (8.0%), akathisia (7.4%).

Conclusions:

Brexpiprazole was effective and well tolerated as adjunctive treatment for MDD patients with an inadequate response to ADT.

Type
E02 - e-Poster Oral Session 02: Depression and Suicide
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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