An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.
The purpose of this study is to evaluate the effectiveness and tolerability of topiramate compared to placebo in patients with binge eating disorder receiving Cognitive Behavior Therapy (CBT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomized, Double-blind Placebo Controlled Trial With Topiramate for the Treatment of Obese Patients With Binge Eating Disorder|
- Weight, Body Mass Index,number of binge eating and anthropometric measurements
- changes in blood pressure, serum triglycerides levels, serum cholesterol levels, beck depression scale scores.
|Study Start Date:||November 2003|
|Study Completion Date:||April 2005|
This was a 21-week multicenter, double-blind, parallel-group, randomized controlled trial comparing the efficacy and tolerability of an add-on treatment with 200mg of topiramate versus placebo in obese patients with BED receiving group CBT. The aim of this trial is to investigate the efficacy and tolerability of adjunctive topiramate to CBT in obese patients with BED through improvement in binge eating, related psychopathology, and weight loss. The study hypothesis is that the patients using topiramate + CBT will loose more weight than patients using placebo + CBT.Tolerability will be investigated through reported adverse events and dropouts, with reasons for leaving the study being analyzed. The randomized patients will receive capsules of topiramate (25 mg, 50 mg) or placebo correspondent daily for 21 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307619
|Study Director:||Janssen-Cilag Farmaceutica Ltda. Clinical Trial||Janssen-Cilag Farmaceutica Ltda.|