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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

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE September 18, 2015
Last Update Posted Date May 14, 2018
Actual Study Start Date  ICMJE October 30, 2015
Actual Primary Completion Date February 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
Frequency of binge eating days as measured by the Eating Disorder Examination Assessment [ Time Frame: 8.5 months ]
The primary outcome is the frequency of binge days
Change History Complete list of historical versions of study NCT02553824 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2018)
  • Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment [ Time Frame: 8.5 months ]
    Frequency of binge episodes
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
  • Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment [ Time Frame: 8.5 months ]
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FDA Approved Medication to Reduce Binge Eating and/or Purging
Official Title  ICMJE Qsymia (Phentermine-topiramate) to Reduce Binge Eating/Purging in Patients With Bulimia Nervosa and Binge Eating Disorder
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge Eating Disorder
  • Bulimia Nervosa
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Phentermine/Topiramate-First
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Phentermine/Topiramate-First
    • Drug: Placebo
Publications * Dalai SS, Adler S, Najarian T, Safer DL. Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa. Contemp Clin Trials. 2018 Jan;64:173-178. doi: 10.1016/j.cct.2017.10.007. Epub 2017 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2015)
60
Actual Study Completion Date  ICMJE April 15, 2017
Actual Primary Completion Date February 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02553824
Other Study ID Numbers  ICMJE 31390
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Debra L. Safer, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Debra L Safer, MD Stanford University
Principal Investigator: Sarah Adler, PsyD Stanford University
Principal Investigator: Shebani Sethi, MD Stanford University
PRS Account Stanford University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP