Asenapine treats bipolar I disorder effectively in pediatric patients and is not affected by the type of current episode, stage of disease progression, or baseline body weight, according to results published in Neuropsychiatric Disease and Treatment.
The study included participants age 10 to 17 years with bipolar I disorder. Participants were randomly assigned to asenapine 2.5, 5.0, or 10.0 mg or placebo twice daily. The researchers stratified participants by current episode type (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-defined mixed/manic), number of lifetime episodes (<3, 3-5, >5), and baseline body mass index tertile. Researchers assessed changes from baseline to day 21 using the Young Mania Rating Scale (YMRS) total score and Clinical Global Impressions Scale for use in Bipolar Illness (CGI-BP).
Among participants with mixed episodes, differences in YMRS and CGI-BP scores were statistically significant for each asenapine dose compared with placebo at day 21 (P <.001).
Among participants with manic episodes, all asenapine dosage groups showed significant differences in YMRS and CGI-BP scores compared with the placebo group (P <.05) with one exception: the 2.5-mg group did not show significant a difference on YMRS scores compared with the placebo group.
Participants with <3 previous mixed/manic episodes had significant difference in YMRS and CGI-BP scores in all asenapine dose groups compared with the placebo group (P <.05). For participants with 3 to 5 or >5 previous episodes, those in the asenapine 10-mg group had significantly different YMRS and CG-BP scores compared with those taking placebo.
The results indicated that baseline body weight or body mass index did not affect the efficacy of asenapine.
Writing assistance and editorial support were provided by Krystina Neuman, PhD, of Prescott Medical Communications Group (Chicago, IL), a contractor of Allergan. The study was sponsored by Merck & Co., Inc. This manuscript was supported by funding from Allergan (Madison, NJ).
Findling RL, Earley W, Suppes T, et al. 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. Neuropsychiatr Dis Treat. 2018;14:1941-1952.