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Latuda longitudinally effective for bipolar depression in children, adolescents
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Sunovion recently published post-hoc analysis results indicating Latuda statistically significantly improved depressive symptoms among children and adolescents with bipolar I disorder.
“Depressive symptoms can be severely debilitating to schoolwork and social activities in children and adolescents living with bipolar disorder, which is recognized as the fourth leading cause of disability among children and adolescents around the world,” study researcher Kiki Chang, MD, of Stanford University Medical Center, said in a press release. “The findings presented today are encouraging, as we need additional treatment options that are well tolerated and can be used on an ongoing basis by children and adolescents who live with bipolar depression.”
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 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 greater 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%).
New findings
Post-hoc item analysis of the CDRS-R endpoint indicated participants who received lurasidone exhibited significantly greater improvement on 13 of 17 CDRS-R items, including social withdrawal, sleep disturbance, listless speech, depressed facial affect, excessive guilt, difficulty having fun, depressed feelings, low self-esteem, excessive weeping, hypoactivity, impaired schoolwork, irritability and appetite disturbance.
Of the 347 participants who completed the 6-week trial, 223 enrolled in a 2-year, open-label, flexible dose, extension study.
Lurasidone was generally well-tolerated among all participants who completed 28 weeks of treatment (n = 155), with similar adverse events to those reported during the 6-week trial.
The most common adverse events occurring in more than 10% of participants included headache (19.7%), somnolence (18.5%) and nausea (14.3%).
Researchers observed minimal effects on weight, metabolic measures and prolactin levels.
From double-blind baseline to week 28, mean change in weight was 3 kg; median change in prolactin was 2 Ng/mL for females and 1.6 Ng/mL for males; median change in total cholesterol was –4.5 mg/dL; –3 mg/dL in LDL cholesterol; –2 mg/dL in triglycerides and 1 mg/dL in glucose.
At 28 weeks, participants who received lurasidone throughout the initial 6-week trial exhibited continued improvement in CDRS-R total score (–7.3) and on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) depression score (–1) in the open-label long-term extension phase.
“Sunovion is committed to advancing the understanding of serious psychiatric conditions,” said Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in the release. “Given the significant impact bipolar depression can have on children and adolescents, it is encouraging to see results that support the potential for Latuda to be an effective and well-tolerated treatment for this population.”
Editor's Note: On Nov. 2, 2017, the sentence regarding change in Clinical Global Impression-Bipolar Version, Severity of Illness scores for depression was changed to reflect the correct difference.