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.
  
  
  METHODS
  Subjects (N = 40) were outpatients of both sexes, 6-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 4(th) 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 +/- 2.1 kg and the weight gain in the olanzapine + topiramate group was statistically significantly lower, 2.6 +/- 3.6 kg.
  
  
  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.
authors.affiliation: Pediatric Psychopharmacology Research Department, Massachusetts General Hospital , Department of Psychiatry at Harvard Medical School, Boston, Massachusetts, USA. jwozniak@partners.org
authors.forename: Janet
authors.initials: J
authors.lastname: Wozniak
authors.forename: Eric
authors.initials: E
authors.lastname: Mick
authors.forename: James
authors.initials: J
authors.lastname: Waxmonsky
authors.forename: Meghan
authors.initials: M
authors.lastname: Kotarski
authors.forename: Liisa
authors.initials: L
authors.lastname: Hantsoo
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D000077152:Olanzapine; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D000077236:Topiramate; D015430:Weight Gain / Q000187:drug effects
chemical_list: D000927:Anticonvulsants; D014150:Antipsychotic Agents; D000077236:Topiramate; D001569:Benzodiazepines; D005632:Fructose; D000077152:Olanzapine