Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight

Robert L Findling,1 Willie Earley,2 Trisha Suppes,3,4 Mehul Patel,2 Xiao Wu,2 Cheng-Tao Chang,2 Roger S McIntyre5 1Johns Hopkins University and the Kennedy Krieger Institute, Baltimore, MD, USA; 2Allergan, Madison, NJ, USA; 3VA Palo Alto Health Care System, Palo Alto, CA, USA; 4Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; 5Toronto Western Research Institute, Toronto, ON, Canada Background: Patient characteristics and disease progression may affect response to pharmacologic intervention in bipolar I disorder. Asenapine is approved for acute treatment of manic/mixed episodes of bipolar I disorder in patients 10–17 years old. Post hoc analyses assessed asenapine efficacy in pediatric patients by current manic or mixed episode, number of lifetime episodes, and baseline body mass index (BMI). Patients and methods: Data were obtained from a 3-week, randomized, double-blind, placebo-controlled, parallel-group trial of asenapine 2.5, 5.0, or 10.0 mg twice daily (BID) in male or female patients (10–17 years) with bipolar I disorder (NCT01244815). Patients were stratified by current episode type (Diagnostic and Statistical Manual of Mental Disorders, fourth edition – defined mixed/manic), number of lifetime episodes (5), and baseline BMI tertile. Changes from baseline to day 21 in Young Mania Rating Scale (YMRS) total score and Clinical Global Impressions Scale for use in Bipolar Illness (CGI-BP) were assessed in asenapine subgroups vs placebo. Results: In patients with mixed episodes, differences in YMRS and CGI-BP scores were statistically significant for each asenapine dose vs placebo (P5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P