NCT02553824

FDA Approved Medication to Reduce Binge Eating and/or Purging

Qsymia (Phentermine-topiramate) to Reduce Binge Eating/Purging in Patients With Bulimia Nervosa and Binge Eating Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa and binge eating disorder.

Detailed description

Bulimia nervosa (BN) and binge eating disorder (BED) are serious mental disorders associated with adverse psychological and physical consequences. Treatment options to date offer limited success, leaving at least 50-70% of patients still symptomatic after treatment. The purpose of the study is to evaluate whether phentermine-topiramate (Qsymia), a medication currently FDA approved for the treatment of obesity, will demonstrate efficacy-compared to placebo- when re-purposed for patients with bulimia and binge eating. Participants will be randomized into one of two conditions: qsymia or Placebo. One condition will receive 3 months of phentermine-topiramate, a 2 week washout, then 3 months of placebo. The other condition will receive 3 months of Placebo, a 2 week washout, then 3 months of phentermine-topiramate. Participants will receive a total of 6 months of treatment and then have a 2 month follow-up off of medications.

Conditions

• Binge Eating Disorder
• Bulimia Nervosa

Interventions

Type	Name	Description
DRUG	Phentermine/Topiramate-First	Patients randomly assigned to this Arm will have a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated). Then will have a 2 week washout followed by a crossover to 12 weeks of control medication/ placebo.
DRUG	Placebo	Patients randomly assigned to this Arm will have begin with 12 weeks of placebo followed by a 2 week washout. They will then crossover to Qsymia and receive a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated).

Timeline

• Start date: 2015-10-30
• Primary completion: 2017-02-23
• Completion: 2017-04-15
• First posted: 2015-09-18
• Last updated: 2018-05-14

Locations

1 site across 1 country: United States