The following article is a part of conference coverage from Psych Congress 2020 Virtual Experience, held virtually from September 10 to 13, 2020. The team at Psychiatry Advisor will be reporting on the latest news and research conducted by leading experts in psychiatry. Check back for more from the Psych Congress 2020.
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.
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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.