Effects of Brexpiprazole on Functioning in Patients With Schizophrenia Who Have Hostility and Agitation Symptoms:...

Objective: People with schizophrenia often experience hostility and agitation, which can worsen their functioning. This post hoc analysis aimed to investigate the effects of brexpiprazole on functioning in schizophrenia in relation to hostility and agitation symptoms.

Methods: Short-term data were pooled from three 6-week, randomized, double-blind, placebo-controlled trials of brexpiprazole tablets in adult inpatients with acute schizophrenia (DSM-IV-TR criteria), conducted at sites worldwide from July 2011 to December 2014. Long-term data were pooled from two 52-week, open-label extension trials conducted from September 2011 to February 2016. Functioning was measured using the Personal and Social Performance (PSP) scale, strengthened by removing the "disturbing and aggressive behaviors" domain to be independent of hostility and agitation. Participants were stratified according to baseline hostility, defined using the Positive and Negative Syndrome Scale (PANSS) hostility item, and agitation, defined using the PANSS-Excited Component subscale.

Results: At baseline, 692/ 1,385 participants (50.0%) had hostility and 784 (56.6%) had agitation. At Week 6, PSP score change (least-squares mean difference [95% confidence interval]) favored brexpiprazole 2-4 mg/day versus placebo in participants with hostility (2.82 [0.58-5.07]; P = .014), without hostility (3.42 [1.37-5.48]; P = .001), and with agitation (4.05 [2.01-6.10]; P < .001), but not those without agitation (2.09 [-0.18 to 4.36]; P = .071). PSP score improved and stabilized over 58 weeks (408 participants analyzed).

Conclusion: Brexpiprazole may improve functioning in adults with schizophrenia, even if they have hostility and agitation symptoms.

Trial Registration: Data used in this post hoc analysis are from the following ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01397786, and NCT01810783.