A medication commonly used in the treatment of schizophrenia is efficacious and well-tolerated as a treatment taken once per month via injection.
John M. Kane, MD, executive vice president for Behavioral Health Services at the North Shore-Long Island Jewish Health System, New York, and colleagues conducted a randomized, placebo-controlled, double-blind study over 12 weeks of aripiprazole once-monthly (Abilify Maintena) in 340 patients. Kane is also a member of Psychiatry Advisor’s editorial board.
The primary outcome was change from baseline to endpoint (week 10) in Positive and Negative Syndrome Scale (PANSS) total score.
Least squares (LS) mean change from baseline to endpoint (week 10) favored aripiprazole once-monthly versus placebo in PANSS total (treatment difference, −15.1 [95% CI, −19.4 to −10.8]; P< .0001), as it did at all other timepoints through 12 weeks (all P ≤ .0005), the researchers reported in the Journal of Clinical Psychiatry.
In an opinion published last month by Psychiatry Advisor, Kane wrote that long-acting injectable antipsychotics (LAIs) benefit patients in terms of improved patient medication adherence and a potential decline in relapses. “The use of LAIs also reduces the frequent confusion and uncertainty between poor/partial response and poor/partial adherence, making treatment decisions easier and more evidence-based.”
The latest study was sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc., the manufacturer of aripiprazole once-monthly.
The objective of the study is to evaluate aripiprazole once-monthly (AOM) (Abilify Maintena), 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.
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