DelBello MP, et al. - The efficacy and safety of lurasidone in children and adolescents with bipolar depression were evaluated in this double-blind, placebo-controlled study. In the dose range of 20-80 mg/day, monotherapy with lurasidone significantly reduced depressive symptoms among children and adolescents with bipolar depression. With minimal effects on weight and metabolic parameters, lurasidone was well-tolerated.

• The authors randomized patients 10-17 years with a DSM-5 diagnosis of bipolar I depression to 6 weeks of double-blind treatment with flexible doses of lurasidone 20-80 mg/day.
• Change from baseline to week 6 in the Children’s Depression Rating Scale–Revised (CDRS-R) total score, evaluated by a mixed model repeated measures analysis was the primary endpoint.

• The authors randomized 347 patients.
• They received at least 1 dose of lurasidone (n=175; mean age, 14.2 years; mean dose, 33.6 mg/day) or placebo (n=172; mean age, 14.3 years).
• Treatment with lurasidone was correlated with statistically significant improvement compared with placebo in CDRS-R total score (-21.0 vs. -15.3; P<.0001; effect size, 0.45) at the primary week 6 endpoint.
• Furthermore, lurasidone was correlated with statistically significant improvement in the Clinical Global Impression-Bipolar-Severity (key secondary measure), and measures of anxiety, quality of life, and global functioning.
• Study completion rates in the lurasidone group were 92.0% and 89.7% in the placebo group.
• For both groups (1.7%), discontinuation rates because of adverse events were same.
• Nausea and somnolence were the two most common adverse events associated with lurasidone.
• Few effects on weight and metabolic parameters were observed with lurasidone treatment.