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Up to 2 years of treatment with lurasidone improved manic symptoms in children and adolescents with bipolar depression, according to a poster presented at Psych Congress 2020.
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.
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—Jolynn Tumolo
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