SAN DIEGO — Data presented at the American Psychiatric Association Annual Meeting indicated Latuda significantly improves depression among children and adolescents, aged 10 to 17 years, with bipolar I depression.
“Children and adolescents with bipolar depression have significant functional impairment, including poor academic and social performance, and they are at very high risk for suicide attempts and self-injurious behavior,” Kiki Chang, MD, of Stanford University Medical Center, said in a press release. “There are few evidence-based treatment options available to help these patients and their families. More treatments are needed that not only improve bipolar depression symptoms in children and adolescents, but are also well-tolerated.”
To determine efficacy of Latuda (lurasidone, Sunovion Pharmaceuticals) for depression associated with bipolar I disorder in children and adolescents, researchers conducted a 6-week, randomized, double-blind, placebo-controlled, parallel-group, multiregional study among 347 children and adolescents aged 10 to 17 years. Study participants received a flexible 20 mg to 80 mg dose of lurasidone or placebo once daily.
From baseline to week 6, change in Children’s Depression Rating Scale, Revised (CDRS-R) total scores was significantly higher among participants who received lurasidone, compared with placebo (–21 vs. –15.3; P < .0001).
Change in Clinical Global Impression-Bipolar Version, Severity of Illness scores for depression was significantly lower among participants who received lurasidone, compared with placebo (–1.49 vs. –1.05; P < .0001).
The most commonly reported treatment-emergent adverse events associated with lurasidone were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%).
Lurasidone was not associated with increases in fasting glucose or lipids.
“It is encouraging to see the potential for Latuda to help children and adolescents living with bipolar depression,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion said in the release. “When bipolar depression strikes in younger years, it can be particularly disabling, so we’re pleased that in this placebo-controlled study, Latuda improved depressive symptoms without causing significant weight gain or metabolic changes in children and adolescents.” – by Amanda Oldt
DelBello MP, et al. Efficacy and safety of lurasidone in children and adolescent patients with bipolar I depression. Presented at: American Psychiatric Association Annual Meeting; May 20-24, 2017; San Diego.
Disclosure: DelBello reports financial ties with Johnson & Johnson, Neuronetics, Inc., Sunovion Pharmaceuticals Inc., Supernus.