Brexpiprazole, a so-called third-generation antipsychotic medication, was shown to be safe and effective in a 65-center, randomized, double-blind, placebo-controlled study of 623 individuals with schizophrenia.
Patients were randomly assigned to received the study drug at a dosage of 0.25, 2, or 4 mg, or placebo for 6 weeks. Investigators evaluated change in positive and negative symptoms from baseline using PANNS scoring as a primary endpoint. They also looked at CGI severity score.
Average PANSS score at baseline was 95.2, and CGI was 4.9. The 2- and 4-mg doses significantly lowered PANSS scores – by 8.72 and 7.64, respectively. CGI scores also went down at these dosages – by 0.33 and 0.38, respectively.
The most common adverse event was akathisia. Weight gain was moderate. There were no changes from baseline in lipid and glucose levels and extrapyramidal symptom ratings.
Citation: Correll C, Skuban A, Ouyang J, et al. Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial. Am J Psychiatry. 2015;172(9):870-880.