Comparison of open-label, 8-week trials of olanzapine monotherapy and topiramate augmentation of olanzapine for the treatment of pediatric bipolar disorder

Janet Wozniak, Eric Mick, James Waxmonsky, Meghan Kotarski, Liisa Hantsoo, Joseph Biederman

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Abstract

Background: The aim of this study was to test the efficacy and safety of olanzapine+topiramate versus olanzapine monotherapy in the treatment of bipolar disorder (BPD) and treatment-attendant weight gain in children and adolescents. Method: Subjects (N=40) were outpatients of both sexes, 6-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of BPD (manic, hypomanic, or mixed) and Young Mania Rating Scale (YMRS) total score of >15 treated over 8-week periods in two partially concurrent open-label trials with olanzapine (n=17) or olanzapine+topiramate (n=23). Results: Subjects in both groups experienced a statistically significant reduction in YMRS scores after 8-week, open-label treatment with olanzapine (baseline YMRS=26.7±9.5; end-point YMRS=18.2±12.5, p=0.04) and olanzapine+topiramate (baseline YMRS=31.3±7.9; end-point YMRS=20.4±11.4, p=0.04). There was no difference in response between the two groups based on YMRS or Clinical Global Impressions-Improvement (CGI-I) scores. Adverse events were few and mild and similar between the two groups, with the exception of weight gain. The weight gain in the olanzapine group was 5.3±2.1kg and the weight gain in the olanzapine+topiramate group was statistically significantly lower, 2.6±3.6kg. Conclusions: Augmentation of olanzapine with topiramate resulted in a reduced weight gain over the course of an 8-week, open-label trial when compared with olanzapine treatment alone, but did not lead to greater reduction in symptoms of mania.

Original languageEnglish (US)
Pages (from-to)539-545
Number of pages7
JournalJournal of Child and Adolescent Psychopharmacology
Volume19
Issue number5
DOIs
StatePublished - Oct 1 2009

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olanzapine
Bipolar Disorder
Pediatrics
Weight Gain
Therapeutics
Diagnostic and Statistical Manual of Mental Disorders
topiramate

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

@article{e092ad42165a4b359ba69187ccacd98c,
title = "Comparison of open-label, 8-week trials of olanzapine monotherapy and topiramate augmentation of olanzapine for the treatment of pediatric bipolar disorder",
abstract = "Background: The aim of this study was to test the efficacy and safety of olanzapine+topiramate versus olanzapine monotherapy in the treatment of bipolar disorder (BPD) and treatment-attendant weight gain in children and adolescents. Method: Subjects (N=40) were outpatients of both sexes, 6-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of BPD (manic, hypomanic, or mixed) and Young Mania Rating Scale (YMRS) total score of >15 treated over 8-week periods in two partially concurrent open-label trials with olanzapine (n=17) or olanzapine+topiramate (n=23). Results: Subjects in both groups experienced a statistically significant reduction in YMRS scores after 8-week, open-label treatment with olanzapine (baseline YMRS=26.7±9.5; end-point YMRS=18.2±12.5, p=0.04) and olanzapine+topiramate (baseline YMRS=31.3±7.9; end-point YMRS=20.4±11.4, p=0.04). There was no difference in response between the two groups based on YMRS or Clinical Global Impressions-Improvement (CGI-I) scores. Adverse events were few and mild and similar between the two groups, with the exception of weight gain. The weight gain in the olanzapine group was 5.3±2.1kg and the weight gain in the olanzapine+topiramate group was statistically significantly lower, 2.6±3.6kg. Conclusions: Augmentation of olanzapine with topiramate resulted in a reduced weight gain over the course of an 8-week, open-label trial when compared with olanzapine treatment alone, but did not lead to greater reduction in symptoms of mania.",
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Comparison of open-label, 8-week trials of olanzapine monotherapy and topiramate augmentation of olanzapine for the treatment of pediatric bipolar disorder. / Wozniak, Janet; Mick, Eric; Waxmonsky, James; Kotarski, Meghan; Hantsoo, Liisa; Biederman, Joseph.

In: Journal of Child and Adolescent Psychopharmacology, Vol. 19, No. 5, 01.10.2009, p. 539-545.

Research output: Contribution to journalArticle

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T1 - Comparison of open-label, 8-week trials of olanzapine monotherapy and topiramate augmentation of olanzapine for the treatment of pediatric bipolar disorder

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AU - Mick, Eric

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AU - Hantsoo, Liisa

AU - Biederman, Joseph

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N2 - Background: The aim of this study was to test the efficacy and safety of olanzapine+topiramate versus olanzapine monotherapy in the treatment of bipolar disorder (BPD) and treatment-attendant weight gain in children and adolescents. Method: Subjects (N=40) were outpatients of both sexes, 6-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of BPD (manic, hypomanic, or mixed) and Young Mania Rating Scale (YMRS) total score of >15 treated over 8-week periods in two partially concurrent open-label trials with olanzapine (n=17) or olanzapine+topiramate (n=23). Results: Subjects in both groups experienced a statistically significant reduction in YMRS scores after 8-week, open-label treatment with olanzapine (baseline YMRS=26.7±9.5; end-point YMRS=18.2±12.5, p=0.04) and olanzapine+topiramate (baseline YMRS=31.3±7.9; end-point YMRS=20.4±11.4, p=0.04). There was no difference in response between the two groups based on YMRS or Clinical Global Impressions-Improvement (CGI-I) scores. Adverse events were few and mild and similar between the two groups, with the exception of weight gain. The weight gain in the olanzapine group was 5.3±2.1kg and the weight gain in the olanzapine+topiramate group was statistically significantly lower, 2.6±3.6kg. Conclusions: Augmentation of olanzapine with topiramate resulted in a reduced weight gain over the course of an 8-week, open-label trial when compared with olanzapine treatment alone, but did not lead to greater reduction in symptoms of mania.

AB - Background: The aim of this study was to test the efficacy and safety of olanzapine+topiramate versus olanzapine monotherapy in the treatment of bipolar disorder (BPD) and treatment-attendant weight gain in children and adolescents. Method: Subjects (N=40) were outpatients of both sexes, 6-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of BPD (manic, hypomanic, or mixed) and Young Mania Rating Scale (YMRS) total score of >15 treated over 8-week periods in two partially concurrent open-label trials with olanzapine (n=17) or olanzapine+topiramate (n=23). Results: Subjects in both groups experienced a statistically significant reduction in YMRS scores after 8-week, open-label treatment with olanzapine (baseline YMRS=26.7±9.5; end-point YMRS=18.2±12.5, p=0.04) and olanzapine+topiramate (baseline YMRS=31.3±7.9; end-point YMRS=20.4±11.4, p=0.04). There was no difference in response between the two groups based on YMRS or Clinical Global Impressions-Improvement (CGI-I) scores. Adverse events were few and mild and similar between the two groups, with the exception of weight gain. The weight gain in the olanzapine group was 5.3±2.1kg and the weight gain in the olanzapine+topiramate group was statistically significantly lower, 2.6±3.6kg. Conclusions: Augmentation of olanzapine with topiramate resulted in a reduced weight gain over the course of an 8-week, open-label trial when compared with olanzapine treatment alone, but did not lead to greater reduction in symptoms of mania.

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