Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression.

ABSTRACT: Objectives: To evaluate long-term safety and effectiveness of lurasidone in children and adolescents with bipolar depression. Methods: Participants, ages 10-17 years, with bipolar depression, who completed 6 weeks of double-blind (DB) treatment with lurasidone or placebo were enrolled in a 2-year, open-label (OL) extension study of lurasidone (20-80 mg/d). The primary effectiveness measure was the Children's Depression Rating Scale, Revised (CDRS-R). Results: A total of 306 participants entered the 2-year extension study; 195 (63.7%) completed 52 weeks, and 168 (54.9%) completed 104 weeks of treatment. For all participants entering the extension study, mean change in CDRS from OL baseline was -13.4 at week 52, and -16.4 at week 104 (-11.3 at last o

SUBMITTER: DelBello MP 

PROVIDER: S-EPMC8568779 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature