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Psych Congress  

Brexpiprazole and Long-term Functioning in Adults With Schizophrenia: Results From a Randomized, Double-blind, Placebo-controlled, Maintenance Study

Authors  
Catherine Weiss, PhD
Mary Hobart, PhD
John Ouyang, PhD
Andy Forbes, PhD;
Emmanuelle Weiller, PsyD
Wolfgang Fleischhacker, MD
Sponsor  
Otsuka Pharmaceutical Commercialization, Inc. / H. Lundbeck A/S

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Brexpiprazole is a serotonin-dopamine activity modulator that is a partial agonist at 5-HT1A and dopamine D2 receptors, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors, all at similar potencies. Brexpiprazole was recently approved in the US for treatment of schizophrenia and as adjunctive treatment for major depressive disorder. We evaluated the effects of brexpiprazole on long-term social functioning based on data from a maintenance trial [NCT01668797]. Patients experiencing an acute exacerbation of schizophrenia were cross-titrated from current antipsychotic treatment(s) to brexpiprazole (1- 4 mg) before entering a 12- to 36-week single-blind stabilization phase. Patients with stable symptoms over 12 consecutive weeks and on a stable dose of brexpiprazole for at least the last 4 weeks were then randomized to either brexpiprazole or placebo for up to 52 weeks. The primary endpoint was time from randomization to exacerbation of psychotic symptoms/impending relapse. Secondary endpoints included two clinician-rated assessments: the Global Assessment of Functioning (GAF) assessed psychological, social, and occupational functioning, and the Personal and Social Performance (PSP) scale assessed socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviors. Ninety-seven patients were randomized to brexpiprazole and 105 to placebo. Compared with placebo, brexpiprazole showed a statistically significant benefit for the primary endpoint at 52 weeks (hazard ratio = 0.292, p<0.0001), GAF scores (p = 0.0001), and PSP total scores (p = 0.0071). Brexpiprazole significantly improved long-term social functioning on the PSP scale, and maintained good overall function on the GAF scale.

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