A Randomized, Double-Blind, Placebo-Controlled Trial of Aripiprazole Lauroxil in Acute Exacerbation of Schizophrenia

• DOI: 10.4088/jcp.14m09741
• Publication Date: 2015-06-09T20:28:35Z
• Authors: Herbert Y. Meltzer; Robert Risinger; Henry A. Nasrallah; Yangchun Du; Jacqueline Zummo; Lisa Corey; Anjana Bose; Srdjan Stankovic; Bernard L. Silverman; Elliot W. Ehrich
• Keywords: Aripiprazole; Tolerability; Akathisia; Placebo-controlled study

Article Abstract Objective: This study evaluated the efficacy, safety, and tolerability of aripiprazole lauroxil, a novel long-acting injectable atypical antipsychotic, for treatment schizophrenia. Method: An international multicenter, randomized, double-blind, placebo-controlled trial was conducted between December 2011 March 2014. Patients (N = 623) aged 18 to 70 years with schizophrenia (DSM-IV-TR criteria), experiencing an acute exacerbation, were randomized in 1:1:1 ratio receive gluteal intramuscular injection lauroxil 441 mg, 882 or matching placebo once monthly 12 weeks. The primary efficacy outcome change Positive Negative Syndrome Scale (PANSS) total score from baseline day 85. Clinical Global Impressions-Improvement scale (CGI-I) at 85 secondary outcome. Safety assessed. Results: PANSS (mean ± standard error ) improved significantly mg groups, placebo-adjusted differences −10.9 1.8 (P < .001) −11.9 .001), respectively. Significant ≤ .004) improvements both active groups demonstrated as early 8 continued throughout period. proportion patients who very much on CGI-I greater versus .001). most common treatment-emergent adverse events insomnia, akathisia, headache, anxiety. incidence site reactions low, predominantly described pain, associated first injection. Conclusions: Aripiprazole robust exacerbation improvement psychotic symptoms statistically significant clinically meaningful. Symptom occurred rapidly after initiation maintained study. Both doses well tolerated. These results support important new option Trial Registration: ClinicalTrials.gov identifier: NCT01469039; Clinicaltrialsregister.eu 2012-003445-15