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Short- and long-term treatment with lurasidone was not found to increase the incidence of treatment-emergent mania among adult and pediatric patients with bipolar 1 depression. These findings, derived from short-term studies with open-label extensions among adults and adolescents, were presented at Psych Congress 2020 Virtual Experience, held online from September 11 to 13, 2020.
Adults with bipolar 1 depression were enrolled in a 6-week, double blind study of either monotherapy or adjunctive therapy with lurasidone. The monotherapy study randomly assigned participants in a 1:1:1 ratio to receive lurasidone 20 to 60 mg/d (n=161), lurasidone 80 to 120 mg/d (n=162), or placebo (n=162). The adjunctive therapy study randomly assigned participants in a 1:1 ratio to receive lurasidone 20 to 120 mg/d with lithium or valproate (n=179) or placebo with lithium or valproate (n=161). Participants were eligible for a 6-month, open-label extension study of monotherapy (n=316) or adjunctive therapy (n=497). The Young Mania Rating Scale (YMRS) was used to evaluate participants for treatment-emergent mania or manic symptoms.
Pediatric patients (N=343) aged 10 to 17 years with bipolar I depression were randomly assigned in a 1:1 ratio to receive lurasidone 20 to 80 mg/d (n=173) or placebo (n=170) for 6 weeks, following which they were eligible for a 24-month, open-label extension (n=305). Participants YMRS and the Clinical Global Impression Bipolar Severity (CGI-BP-S) scores were assessed weekly during the first stage and monthly during the second stage. Treatment-emergent mania was defined as a YMRS score ³16 during 2 consecutive weekly or 1 monthly examination or by experiencing an adverse event of mania or hypermania.
At the conclusion of the short-term study among adults, instances of treatment-emergent mania were similar between placebo and lurasidone high-dose monotherapy (1.9% vs 1.9%, respectively) and placebo and lurasidone adjunctive therapy (1.1% vs 1.2%, respectively). An increase in treatment-emergent mania, although nonsignificant, was observed among the low-dose lurasidone monotherapy group (3.7%).
When all adult lurasidone recipients were pooled, significant improvements in motor activity (P <.05), sleep (P <.01), irritability (P <.01), speech (P <.01), and thought disorder (P <.01) were observed compared with those receiving placebo.
At the conclusion of the long-term extension among adults, instances of treatment-emergent mania were observed among 1.3% of monotherapy and 3.8% of adjunctive therapy recipients compared with 2.8% and 4.9%, respectively, among their respective placebo groups.
The occurrence of treatment-emergent mania among pediatric participants was similar between the treatment and placebo groups during the first stage of the study (1.7% vs 2.3%, respectively). A significantly greater decrease in YMRS score was reported for the treatment group vs the placebo group (-2.0 vs -1.1, respectively; P <.05). After 2 years of treatment, 5.2% of lurasidone recipients met the clinical criteria for treatment-emergent mania.
A limitation of this pooled analysis was the comparison of studies with differing treatments and durations.
The study authors concluded that both short- and long-term lurasidone therapy was efficacious for the treatment of treatment-emergent mania and manic symptoms among adults and adolescents with bipolar 1 depression.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures. Visit Psychiatry Advisor’s meetings section for complete coverage of Psych Congress 2020.
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Tocco M, Pikalov A, Zeni C, Goldman R. Effect of lurasidone on manic symptoms and treatment-emergent mania in children and adolescents with bipolar depression. Presented at: Psych Congress 2020 Virtual Experience; September 10-13, 2020. Poster 144.
This article originally appeared on Psychiatry Advisor