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, Willie Earley, Trisha Suppes, Mehul Patel, Xiao Wu, Cheng Tao Chang, Roger S. McIntyre

Research output: Contribution to journalArticle

Abstract

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 (<3, 3–5, >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 (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI.

Original languageEnglish (US)
Pages (from-to)1941-1952
Number of pages12
JournalNeuropsychiatric Disease and Treatment
Volume14
DOIs
StatePublished - Jan 1 2018

Fingerprint

Bipolar Disorder
Body Weight
Pediatrics
Placebos
Body Mass Index
Therapeutics
Disease Progression
Asenapine
Diagnostic and Statistical Manual of Mental Disorders

Keywords

  • Adolescent
  • Asenapine
  • Atypical antipsychotic
  • Bipolar disorder
  • Child
  • Second-generation antipsychotic

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

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. / Findling, Robert L; Earley, Willie; Suppes, Trisha; Patel, Mehul; Wu, Xiao; Chang, Cheng Tao; McIntyre, Roger S.

In: Neuropsychiatric Disease and Treatment, Vol. 14, 01.01.2018, p. 1941-1952.

Research output: Contribution to journalArticle

@article{5de4bbc84c5c4ea99425d7072ccb69f6,
title = "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",
abstract = "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 (<3, 3–5, >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 (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI.",
keywords = "Adolescent, Asenapine, Atypical antipsychotic, Bipolar disorder, Child, Second-generation antipsychotic",
author = "Findling, {Robert L} and Willie Earley and Trisha Suppes and Mehul Patel and Xiao Wu and Chang, {Cheng Tao} and McIntyre, {Roger S.}",
year = "2018",
month = "1",
day = "1",
doi = "10.2147/NDT.S165743",
language = "English (US)",
volume = "14",
pages = "1941--1952",
journal = "Neuropsychiatric Disease and Treatment",
issn = "1176-6328",
publisher = "Dove Medical Press Ltd.",

}

TY - JOUR

T1 - Post hoc analyses of asenapine treatment in pediatric patients with bipolar i disorder

T2 - Efficacy related to mixed or manic episode, stage of illness, and body weight

AU - Findling, Robert L

AU - Earley, Willie

AU - Suppes, Trisha

AU - Patel, Mehul

AU - Wu, Xiao

AU - Chang, Cheng Tao

AU - McIntyre, Roger S.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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 (<3, 3–5, >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 (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI.

AB - 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 (<3, 3–5, >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 (P<0.001) at day 21; in patients with manic episodes, significant differences vs placebo were seen in all groups (P<0.05) except 2.5 mg BID on the YMRS. In patients with <3 previous mixed/manic episodes, significant differences in YMRS and CGI-BP scores were observed for all asenapine doses vs placebo (P<0.05). In patients with 3–5 or >5 previous episodes, asenapine 10 mg BID was significantly different than placebo (P<0.05) on both scales; differences vs placebo varied for lower doses. Baseline body weight or BMI did not appear to influence the efficacy of asenapine. Conclusion: Asenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI.

KW - Adolescent

KW - Asenapine

KW - Atypical antipsychotic

KW - Bipolar disorder

KW - Child

KW - Second-generation antipsychotic

UR - http://www.scopus.com/inward/record.url?scp=85057520600&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85057520600&partnerID=8YFLogxK

U2 - 10.2147/NDT.S165743

DO - 10.2147/NDT.S165743

M3 - Article

C2 - 30122926

AN - SCOPUS:85057520600

VL - 14

SP - 1941

EP - 1952

JO - Neuropsychiatric Disease and Treatment

JF - Neuropsychiatric Disease and Treatment

SN - 1176-6328

ER -