Researchers assessed the effect of lurasidone on both manic symptoms and treatment-emergent mania in pediatric patients with bipolar depression.
The study started with a 6-week double-blind trial in which 173 participants were randomized to lurasidone 20-80 mg/day and 170 to placebo. Pediatric patients treated with lurasidone had a significantly greater average reduction in mania symptoms (-2) on the Young Mania Rating Scale, compared with patients treated with placebo (-1.1), researchers reported. Rates of treatment-emergent mania were comparable among participants treated with lurasidone (1.7%) and patients treated with placebo (2.3%).
Upon completion of the 6-week trial, 305 pediatric patients entered a 24-month open-label extension study of lurasidone 20-80 mg/day. At the end of the 2 years, 5.2% of participants met criteria for treatment-emergent mania. From double-blend baseline through month 24, the average total score on the Young Mania Rating Scale dropped by 2 points.
“Over 2 years of lurasidone therapy, treatment-emergent mania was only observed in a small proportion of patients,” researchers wrote. “Both short- and long-term treatment with lurasidone demonstrated improvement in manic symptoms in this patient population.”
Sunovion Pharmaceuticals Inc. sponsored the study.
Tocco M, Pikalov A, Zeni C, Goldman R. Effect of lurasidone on manic symptoms and treatment-emergent mania in children and adolescents with bipolar depression. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.