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FDA Approved Medication to Reduce Binge Eating and/or Purging

NCT02553824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-05-14

No results posted yet for this study

Summary

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

Conditions

  • Binge Eating Disorder
  • Bulimia Nervosa

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Debra L Safer, MD · Stanford University

  • Sarah Adler, PsyD · Stanford University

  • Shebani Sethi, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2017-02-23
Completion
2017-04-15

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02553824 on ClinicalTrials.gov