A pilot controlled trial of topiramate for mania in children and adolescents with bipolar disorder.
OBJECTIVE
To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type I.


METHODS
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.
Delbello
Melissa P
MP
Center for Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, OH 45267-0559, USA. delbelmp@email.uc.edu
Findling
Robert L
RL
Kushner
Stuart
S
Wang
Daniel
D
Olson
William H
WH
Capece
Julie A
JA
Fazzio
Lydia
L
Rosenthal
Norman R
NR
D000208:Acute Disease; D000293:Adolescent; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D000077236:Topiramate; D016896:Treatment Outcome
D018692:Antimanic Agents; D000077236:Topiramate; D005632:Fructose