© COPYRIGHT 2003 PHYSICIANS POSTGRADUATE PRESS, I NC. © COPYRIGHT 2003 PHYSICIANS POSTGRADUATE PRESS, I NC. Hoopes et al. 1336 J Clin Psychiatry 64:11, November 2003 ulimia nervosa is a chronic disorder involving repeated episodes of uncontrolled binge eating, Treatment of Bulimia Nervosa With Topiramate in a Randomized, Double-Blind, Placebo-Controlled Trial, Part 1: Improvement in Binge and Purge Measures Scott P. Hoopes, M.D.; Frederick W. Reimherr, M.D.; Dawson W. Hedges, M.D.; Norman R. Rosenthal, M.D.; Marc Kamin, M.D.; Rezaul Karim, Ph.D.; Julie A. Capece, B.A.; and Debra Karvois, M.S. 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 ner- vosa 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 base- line 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. (J Clin Psychiatry 2003;64:1335–1341) Received Feb. 3, 2003; accepted May 31, 2003. From Mountain West Clinical Trials, Boise, Idaho (Dr. Hoopes); University of Utah Health Sciences Center, Salt Lake City (Dr. Reimherr); Brigham Young University, Provo, Utah (Dr. Hedges); and Ortho-McNeil Pharmaceutical, Raritan, N.J. (Drs. Rosenthal, Kamin, and Karim and Mss. Capece and Karvois). Supported by Ortho-McNeil Pharmaceutical, Inc., Raritan, N.J. Data from this study were presented at the 155th annual meeting of the American Psychiatric Association, May 18–23, 2002, Philadelphia, Pa. Dr. Hoopes has received grant/research support from GlaxoSmithKline and Lilly; has received honoraria from GlaxoSmithKline, Lilly, and Organon; and has participated in a speakers/advisory board for GlaxoSmithKline. Dr. Reimherr has received grant/research support and honoraria from and been a consultant and speaker/advisory board member for Johnson & Johnson. Dr. Rosenthal and Ms. Capece are employees of Ortho-McNeil. Dr. Kamin and Ms. Karvois are employees of and major stock shareholders in Ortho-McNeil. Dr. Karim is an employee of and major stock shareholder in Johnson & Johnson. Corresponding author and reprints: Scott P. Hoopes, M.D., Mountain West Clinical Trials, 315 North Allumbaugh St., Boise, ID 83704 (e-mail: hoopes@cableone.net). B followed by inappropriate compensatory behaviors such as self-induced purging, fasting, inappropriate use of diuretics or laxatives, and excessive exercise. The inci- dence of bulimia nervosa peaks during adolescence and young adulthood, 1 and the disorder may affect up to 5% of adolescent females in the United States. 2 Eating disorders during adolescence have been corre- lated with poor health outcomes in early adulthood. In a recent study, 62% of adolescents with eating disorders had 2 or more chronic physical health problems during early adulthood, including cardiovascular conditions such as hypertension, fatigue, and migraine headaches, as com- pared with 22% of those without psychiatric disorders and 32% of those with psychiatric disorders other than eating disorders. 3 Furthermore, those who employed self- induced vomiting as a compensatory method of weight gain prevention were more likely to endure adverse health outcomes such as respiratory illnesses, chronic pain, or migraine headaches in early adulthood as compared with those who used fasting, frequent exercise, or dieting. Treatment options for bulimia nervosa encompass both nonpharmacologic and pharmacologic approaches. 1335