TY - JOUR
T1 - A pilot controlled trial of topiramate for mania in children and adolescents with bipolar disorder
AU - Delbello, Melissa P.
AU - Findling, Robert L.
AU - Kushner, Stuart
AU - Wang, Daniel
AU - Olson, William H.
AU - Capece, Julie A.
AU - Fazzio, Lydia
AU - Rosenthal, Norman R.
N1 - Funding Information:
This study was supported by a grant from Johnson & Johnson Pharmaceutical Research & Development, LLC. The authors thank Robert Kowatch for standardizing raters for psychometric testing, Li-Joy Wang for assistance with statistical analyses, Jonathan Latham for assistance in preparing the manuscript, and Alan Unis for assistance with protocol development. The authors acknowledge contributions from the following study consultants and investigators: Valerie Arnold, Memphis; Charles Bailey, Orlando, FL; Mark Bangs, Indianapolis; Jeffrey Blumer, Cleveland; Sharon Cain, Kansas City, KS; Gabrielle Carlson, Stony Brook, NY; Kiki Chang, Stanford, CA; Joseph Haraszti, Cerritos, CA; Arnold Hartman, West Palm Beach, FL; Willis Holloway, Oklahoma City; Alan Jacobson, Hollywood, FL; Vivian Kafantaris, Glen Oaks, NY; Alain Katic, Bellaire, TX; Arifula Khan, Bellevue, WA; Robert Kowatch, Cincinnati; Adam Lowy, Washington, DC; Morteza Marandi, Cerritos, CA; William Murphy, Overland Park, KS; Steven Pliszka, San Antonio, TX; Michael Plopper, San Diego; Sohail Punjwani, North Miami, FL; Joachim Raese, Riverside, CA; Adelaide Robb, Washington, DC; David Sack, Cerritos, CA; Russell Scheffer, Dallas; Scott Segal, North Miami, FL; J. Stone, Austin, TX; Tram Tran-Johnson, San Diego; Himanshu Upadhyaya, Charleston, SC; Amit Vijapura, Jacksonville, FL; Karen Wagner, Galveston, TX; Elizabeth Weller, Merion Station, PA; Craig Wronski, Pico Rivera, CA; Kashinath Yadalam, Lake Charles, LA.
PY - 2005/6
Y1 - 2005/6
N2 - Objective: To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type I. Method: This double-blind, placebo-controlled study was discontinued early when adult mania trials with topiramate failed to show efficacy. Efficacy end points included the Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale for Children, Children's Depression Rating Scale, Children's Global Assessment Scale, and Clinical Global Impressions-Improvement. Results: Fifty-six children and adolescents (6-17 years) with a diagnosis of bipolar disorder type I received topiramate (n = 29, 52%) or placebo (n = 27, 48%). The only statistically significant differences in efficacy measures between treatment groups were the difference between slopes of the linear mean profiles of the YMRS (p = .003) using a post hoc repeated measures regression and the change in Brief Psychiatric Rating Scale for Children at day 28 (-14.9 versus -5.9, p = .048) using observed data. Adverse events with topiramate included decreased appetite, nausea, diarrhea, and paresthesia. Conclusions: Topiramate was well tolerated; however, the results are inconclusive because of premature termination resulting in a limited sample size. Adequately powered controlled trials are necessary to determine whether topiramate has efficacy in reducing symptoms of acute mania in children and adolescents.
AB - Objective: To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type I. Method: This double-blind, placebo-controlled study was discontinued early when adult mania trials with topiramate failed to show efficacy. Efficacy end points included the Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale for Children, Children's Depression Rating Scale, Children's Global Assessment Scale, and Clinical Global Impressions-Improvement. Results: Fifty-six children and adolescents (6-17 years) with a diagnosis of bipolar disorder type I received topiramate (n = 29, 52%) or placebo (n = 27, 48%). The only statistically significant differences in efficacy measures between treatment groups were the difference between slopes of the linear mean profiles of the YMRS (p = .003) using a post hoc repeated measures regression and the change in Brief Psychiatric Rating Scale for Children at day 28 (-14.9 versus -5.9, p = .048) using observed data. Adverse events with topiramate included decreased appetite, nausea, diarrhea, and paresthesia. Conclusions: Topiramate was well tolerated; however, the results are inconclusive because of premature termination resulting in a limited sample size. Adequately powered controlled trials are necessary to determine whether topiramate has efficacy in reducing symptoms of acute mania in children and adolescents.
KW - Bipolar disorder
KW - Mania
KW - Topiramate
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U2 - 10.1097/01.chi.0000159151.75345.20
DO - 10.1097/01.chi.0000159151.75345.20
M3 - Article
C2 - 15908836
AN - SCOPUS:19344363150
SN - 0890-8567
VL - 44
SP - 539
EP - 547
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 6
ER -