Aripiprazole Once-Monthly in the Acute Treatment of Schizophrenia: Findings From a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study
Publication Date
2014
Journal Title
Journal of Clinical Psychiatry
Abstract
Objective: To evaluate aripiprazole once-monthly (AOM), a long-acting injectable suspension of aripiprazole, as acute treatment in patients with schizophrenia (DSM-IV-TR). Method: Adults experiencing an acute psychotic episode were randomized to 12 weeks of double-blind treatment with AOM 400 mg or placebo (October 2012-August 2013). The primary efficacy outcome was change from baseline to endpoint (week 10) in Positive and Negative Syndrome Scale (PANSS) total score. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale (PSP) scores. The study took place from October 2012 through August 2013. Results: Patients (N = 340; 79% male, 66% black) were randomized to AOM (n = 168) or placebo (n = 172). Least squares (LS) mean change from baseline to endpoint (week 10) favored AOM versus placebo in PANSS total (treatment difference, -15.1 [95% CI, -19.4 to -10.8]; P < .0001) and CGI-S (treatment difference, -0.8 [95% CI, -1.1 to -0.6]; P < .0001) scores, as it did at all other timepoints through 12 weeks (all P = .0005). LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo (P < .0001). Common (>10%) treatment-emergent adverse events (AOM vs placebo) were increased weight (16.8% vs 7.0%), headache (14.4% vs 16.3%), and akathisia (11.4% vs 3.5%). Conclusions: Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia, with acceptable safety and tolerability. These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode. (C) Copyright 2014 Physicians Postgraduate Press, Inc.
Volume Number
75
Issue Number
11
Pages
1254-1260
Document Type
Article
EPub Date
2014/09/05
Status
Faculty
Facility
School of Medicine
Primary Department
Psychiatry
Additional Departments
Molecular Medicine
PMID
DOI
10.4088/JCP.14m09168