Abstract
The successful treatment of schizophrenia entails improvement across a spectrum of symptoms. The aim of this post hoc analysis was to characterize the short- and long-term effects of brexpiprazole on Positive and Negative Syndrome Scale (PANSS) ‘Marder factors’. Data were included from three 6-week, randomized, double-blind, placebo-controlled studies; a 52-week, randomized, double-blind, placebo-controlled maintenance treatment study; and two 52-week open-label extension (OLEx) studies – all in schizophrenia (DSM-IV-TR criteria). Patients receiving oral brexpiprazole were dosed at 2–4 mg/day (short-term studies) or 1–4 mg/day (long-term studies). At Week 6, least squares mean differences (LSMDs, with 95% confidence limits) for brexpiprazole (n=868) versus placebo (n=517) were: Positive symptoms: -1.55 (-2.30, -0.80), p<0.0001, Cohen’s d effect size (ES)=0.27; Negative symptoms: -1.12 (-1.63, -0.61), p<0.0001, ES=0.29; Disorganized thought: -1.26 (-1.78, -0.74), p<0.0001, ES=0.32; Uncontrolled hostility/excitement: -0.76 (-1.15, -0.37), p=0.0002, ES=0.26; Anxiety/depression: -0.56 (-0.91, -0.22), p=0.0014, ES=0.22. At last visit of the maintenance study, LSMDs (95% confidence limits) for brexpiprazole (n=96) versus placebo (n=104) were: Positive symptoms: -3.44 (-4.99, -1.89), p<0.0001, ES=0.62; Negative symptoms: -1.23 (-2.52, 0.07), p=0.063, ES=0.27; Disorganized thought: -1.69 (-2.81, -0.56), p=0.0035, ES=0.42; Uncontrolled hostility/excitement: -1.26 (-2.12, -0.39), p=0.0046, ES=0.41; Anxiety/depression: -0.72 (-1.47, 0.03), p=0.061, ES=0.27. In the OLEx studies, improvements were maintained over 58 (6 + 52) weeks of brexpiprazole treatment. In conclusion, these data suggest that brexpiprazole treats the continuum of schizophrenia symptoms, in the short- and long-term. Trial Registration: Data used in this post hoc analysis came from ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01668797, NCT01397786, NCT01810783.