SAN FRANCISCO — In a 2-year open-label extension study presented at the APA annual meeting, long-term treatment with Latuda was generally well-tolerated, and was associated with high rates of study completion, among children and teenagers with bipolar disorder.
“This disorder affects approximately 1.7% of the pediatric population in the U.S.,” Robert Goldman, PhD, head of global clinical research & medical affairs at Sunovion, told Healio Psychiatry. “Latuda is indicated for the treatment of depressive episodes associated with bipolar I disorder in pediatric patients 10 to 17 years, as monotherapy. Considering this along with the cyclical nature of the disease, it is important to evaluate the long-term safety and efficacy of lurasidone in children and adolescents with bipolar depression.”
To examine the long-term safety and efficacy of Latuda (lurasidone, Sunovion Pharmaceuticals) youth with bipolar I depression aged 10 to 17 years randomized to 6 weeks of double-blind treatment with lurasidone or placebo. Those who completed the study could enroll in a 2-year, open-label extension study where they continued to receive flexibly dosed lurasidone (20 mg to 80 mg per day) or switched from placebo to lurasidone.
The researchers measured change in the Children’s Depression Rating Scale, Revised (CDRS-R) total score from baseline. Patients were considered responders if they experienced a 50% reduction from double-blind baseline in the CDRS-R total score.
Of 306 patients who completed the 6-week double-blind study and entered the extension study, 195 (63.7%) completed 52 weeks and 168 (54.9%) completed 104 weeks of treatment. The researchers observed continued improvement in depressive symptoms during long-term treatment with lurasidone.
“Results of this study found that in children and adolescents (aged 10 to 17 years) with bipolar depression, long-term treatment with lurasidone was generally well-tolerated,” Goldman told Healio Psychiatry. “Additionally, continued improvement in depressive symptoms was observed during long-term treatment with lurasidone.”
In the double-blind study, the average CDRS-R total score at week 6-endpoint was lower in the lurasidone group than in the placebo group (36.6 vs. 41.9), according to the abstract. In the open-label extension study, the average change in CDRS-R score among patients who received lurasidone was –13.4 at week 52 and –16.4 at week 104. Responder rates were 51% at open-label baseline, 88.4% at week 52, and 73.2% at week 104, the researchers reported.
During open-label treatment with lurasidone, the most commonly reported adverse events were headache (23.9%) and nausea (16.4%); lurasidone was linked to few effects on weight, metabolic parameters or prolactin, according to the poster. – by Savannah Demko
Delbello M, et al. Efficacy and safety of lurasidone in children and adolescents with bipolar depression: Results from a 2-year open-label extension study. Presented at: APA Annual Meeting; May 18-23, 2019; San Francisco.
Disclosures: Goldman is an employee of Sunovion.