Background: The aim of this analysis was to evaluate the long-term efficacy of lurasidone in achieving response and remission in children and adolescents with bipolar depression.
Methods: Patients 10-17 years with bipolar I depression who completed a 6-week double-blind (DB) study of lurasidone vs. placebo enrolled in a 2-year, open-label (OL) study of lurasidone (20-80 mg/d). Efficacy measures included the Children’s Depression Rating Scale, Revised (CDRS-R) and the Clinical Global Impression, Bipolar Depression Severity scale (CGI-BP-S). Functioning was evaluated utilizing the Clinician-rated Children’s Global Assessment Scale (CGAS) score (score ≥70: no functional impairment). Response criteria: ≥50% reduction from DB baseline in the CDRS-R score; remission criteria: CDRS-R Score ≤28, YMRS score ≤8, and CGI-BP-S score ≤3; and recovery criteria: in remission with a CGAS score ≥70.
Results: A total of 305 patients completed the 6-week DB study and entered the extension study; 195 and 93 completed 52 and 104 weeks of treatment, respectively. Responder rates at OL baseline, and weeks 52 and 104 were 51.0%, 88.4% and 91.1%, respectively; remission rates were 24.3%, 61.3%, and 75.6%, respectively; and recovery rates were 17.7%, 53.8%, and 73.8%. On a Pearson correlation analysis, there was a strong inverse relationship (r = -0.71) between CDRS-R total score, and global functioning as measured by the CGAS.
Conclusions: In children and adolescents with bipolar depression, up to 2 years of treatment with lurasidone was associated with continued improvement in depressive symptoms, resulting in progressively higher rates of remission, recovery, and sustained remission.