FDA Approved Medication to Reduce Binge Eating and/or Purging

Not Recruiting

Trial ID: NCT02553824


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

Official Title

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

Stanford Investigator(s)

Debra Safer
Debra Safer

Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology-Adult)

Shebani Sethi MD, ABOM

Clinical Associate Professor, Psychiatry and Behavioral Sciences


Inclusion Criteria:

   - Must meet Diagnostic and Statistical Manual -Edition 5 criteria for bulimia or binge
   eating disorder, which has not responded to prior treatment

   - Men and women between the ages of 18-60

   - Must be at least normal weight (i.e. body mass index at least 21.0 or greater)

   - If female of child-bearing potential, the participant must have an initial negative
   pregnancy test and be taking adequate birth control

   - must be medically stable with no new diagnoses (medical, surgical, or psychiatric)
   within the past 6 months

   - Must live close enough or be within commute distance of study site (Stanford, CA) to
   be able to comply with study visits, treatment plans, and blood draws and other
   possible assessments (i.e. EKG)

Exclusion Criteria:

   - Any patient with bipolar disease or schizophrenia or any patient taking a mood
   stabilizer or antipsychotic medication within the past 3 months

   - Any patient with current or past history of anorexia nervosa (i.e., with a Body mass
   index of < 17.5).

   - Any patient with prior (within 30 days) use of Over The Counter (OTC) weight-reducing
   agents, herbal preparations

   - Any patient who has been prescribed a medication for weight loss within the past 3

   - Any psychological weight-loss interventions (i.e., Weight Watchers, Jenny Craig) in
   which patient has lost weight over the past month (unless willing to discontinue).

   - Any patient currently in therapy with a psychostimulant or who has used a
   psychostimulant within the past 6 months

   - Any patient with known sensitivity to phentermine or topiramate

   - Any patient who has had a change in thyroid, psychiatric, or blood pressure
   medications within the past one month

   - Any patient who is taking a potassium-wasting diuretic

   - Any patient who is on a carbonic anhydrase inhibitor such as zonisamide acetazolamide,
   or dichlorphenamide

   - Any diabetic who is taking insulin or an insulin secretagogue

   - Any patient with liver enzymes at baseline greater than three times the upper limit of

   - Any patient with a baseline potassium of less than 3.0 millequivalent/Liter. Patients
   with baseline potassium levels between 3.0-3.5 miliEquivalents/Liter will be
   encouraged to ingest high potassium foods such as bananas, oranges, or tomato juice
   daily during the study

   - Any patient with abnormal baseline thyroid test or with a Thyroid Stimulating Hormone
   (TSH) greater than 1.5 times the upper limit of normal

   - Any patient who is unwilling or expresses uncertainty about being able to refrain from
   daily alcohol use (even if at moderate levels) or illegal drugs while taking the study

   - Any adult with recent history of suspected alcohol or substance abuse or substance

   - Any patient who regularly uses marijuana (including medical marijuana) or illegal

   - Any patient who has a history of addiction to a stimulant

   - Any patient who expresses current suicidal ideation

   - Any patient with a history of nephrolithiasis

   - Any patient who is pregnant or who is planning to become pregnant during the study

   - Any patient who is currently participating in any other clinical study that involves
   an active treatment

   - Any patient who is unable to identify a primary care physician

   - Any patient with a history of cardiovascular disease (i.e. recent history of
   Myocardial Infarction, stroke, shortness of breath, chest pain) that could increase
   vulnerability to the sympathomimetic effects of a stimulant like drug. If clinical
   suspicion is high, baseline EKG will be obtained and anyone with abnormal findings
   will be excluded


drug: Phentermine/Topiramate-First

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debra L Safer, MD