FDA Approved Medication to Reduce Binge Eating and/or Purging

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.

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
months

- 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
normal

- 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
medication.

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

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

- 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
period.

- 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