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FDA Approved Medication to Reduce Binge Eating and/or Purging

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ClinicalTrials.gov Identifier: NCT02553824
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Debra L. Safer, Stanford University

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

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Bulimia Nervosa Drug: Phentermine/Topiramate-First Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Qsymia (Phentermine-topiramate) to Reduce Binge Eating/Purging in Patients With Bulimia Nervosa and Binge Eating Disorder
Actual Study Start Date : October 30, 2015
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Phentermine/Topiramate-First + Placebo
Patients randomly assigned to this condition will receive the study medication first, have a 2 week washout, and then crossover to receive the control medication/placebo
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.
Other Name: Qsymia

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).
Other Name: Placebo-First

Placebo Comparator: Placebo-First + Phentermine/Topiramate
Patients randomly assigned to this condition will receive the control medication (placebo) first followed by a 2 week washout, and then receive the study medication.
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.
Other Name: Qsymia

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).
Other Name: Placebo-First




Primary Outcome Measures :
  1. Frequency of binge eating episodes as measured by the Eating Disorder Examination Assessment [ Time Frame: 8.5 months ]
    The primary outcome is the frequency of binge episodes


Secondary Outcome Measures :
  1. Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment [ Time Frame: 8.5 months ]
    Frequency of binge episodes

  2. Percentage of Abstinence from Binge Eating as Measured by the Eating Disorder Examination Assessment [ Time Frame: 8.5 months ]
    Percentage of patients who have had no binge episodes as assessed by the EDE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553824


Locations
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United States, California
Stanford School of Medicine, Psychiatry and Behavioral Sciences
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Debra L Safer, MD Stanford University
Principal Investigator: Sarah Adler, PsyD Stanford University
Principal Investigator: Shebani Sethi, MD Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Debra L. Safer, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02553824     History of Changes
Other Study ID Numbers: 31390
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Debra L. Safer, Stanford University:
binge eating
bulimia nervosa
binge eating disorder
eating disorder treatment

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Topiramate
Phentermine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action