Abstract | BACKGROUND: This randomized, double-blind, placebo-controlled trial was designed to assess the efficacy and safety of topiramate in bulimia nervosa. METHOD: Patients with DSM-IV bulimia nervosa were randomly assigned in equal proportions to receive topiramate (N = 35) or placebo (N = 34) for 10 weeks (between April 1999 and Dec. 2000). Topiramate treatment was started at 25 mg/day and titrated by 25 to 50 mg/week to a maximum of 400 mg/day. The primary efficacy measure was mean weekly number of binge and/or purge days. Related outcome measures included mean weekly number of binge days and binge frequency, as well as mean weekly number of purge days and purge frequency. RESULTS: Sixty-four outpatients (33 placebo, 31 topiramate) were included in the intent-to-treat analysis. The median topiramate dose was 100 mg/day (range, 25-400 mg/day). Mean +/- SD baseline number of weekly binge and/or purge days was 5.0 +/- 1.6 for topiramate patients and 5.1 +/- 1.5 for placebo patients. The primary efficacy measure, mean weekly number of binge and/or purge days, decreased 44.8% from baseline with topiramate versus 10.7% with placebo (p =.004). The mean weekly number of binge days decreased 48.2% with topiramate versus 17.7% with placebo (p =.015), and mean binge frequency decreased 49.2% with topiramate versus 28.0% with placebo ( p =.071). The mean weekly number of purge days decreased 43.4% with topiramate versus 16.6% with placebo (p =.016), and mean purge frequency decreased 49.8% with topiramate versus 21.6% with placebo (p =.016). Three patients (2 placebo, 1 topiramate) discontinued from the trial due to adverse events. CONCLUSION:
Topiramate was associated with significant improvements in both binge and purge symptoms in this study population and represents a potential treatment for bulimia nervosa.
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Authors | Scott P Hoopes, Frederick W Reimherr, Dawson W Hedges, Norman R Rosenthal, Marc Kamin, Rezaul Karim, Julie A Capece, Debra Karvois |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 64
Issue 11
Pg. 1335-41
(Nov 2003)
ISSN: 0160-6689 [Print] United States |
PMID | 14658948
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticonvulsants
- Placebos
- Topiramate
- Fructose
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Topics |
- Administration, Oral
- Adult
- Anticonvulsants
(administration & dosage, pharmacology, therapeutic use)
- Bulimia
(drug therapy, psychology)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Feeding Behavior
(drug effects)
- Female
- Fructose
(administration & dosage, analogs & derivatives, pharmacology, therapeutic use)
- Humans
- Male
- Outpatients
- Placebos
- Topiramate
- Treatment Outcome
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