FDA Approved Medication to Reduce Binge Eating and/or Purging
Primary Purpose
Binge Eating Disorder, Bulimia Nervosa
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Phentermine/Topiramate-First
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating Disorder focused on measuring binge eating, bulimia nervosa, binge eating disorder, eating disorder treatment
Eligibility 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
Sites / Locations
- Stanford School of Medicine, Psychiatry and Behavioral Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Phentermine/Topiramate-First + Placebo
Placebo-First + Phentermine/Topiramate
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Frequency of binge eating episodes as measured by the Eating Disorder Examination Assessment
The primary outcome is the frequency of binge episodes
Secondary Outcome Measures
Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment
Frequency of binge episodes
Percentage of Abstinence from Binge Eating as Measured by the Eating Disorder Examination Assessment
Percentage of patients who have had no binge episodes as assessed by the EDE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02553824
Brief Title
FDA Approved Medication to Reduce Binge Eating and/or Purging
Official Title
Qsymia (Phentermine-topiramate) to Reduce Binge Eating/Purging in Patients With Bulimia Nervosa and Binge Eating Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 30, 2015 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
April 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Bulimia Nervosa
Keywords
binge eating, bulimia nervosa, binge eating disorder, eating disorder treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phentermine/Topiramate-First + Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo-First + Phentermine/Topiramate
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Phentermine/Topiramate-First
Other Intervention Name(s)
Qsymia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo-First
Intervention Description
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).
Primary Outcome Measure Information:
Title
Frequency of binge eating episodes as measured by the Eating Disorder Examination Assessment
Description
The primary outcome is the frequency of binge episodes
Time Frame
8.5 months
Secondary Outcome Measure Information:
Title
Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment
Description
Frequency of binge episodes
Time Frame
8.5 months
Title
Percentage of Abstinence from Binge Eating as Measured by the Eating Disorder Examination Assessment
Description
Percentage of patients who have had no binge episodes as assessed by the EDE
Time Frame
8.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra L Safer, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Adler, PsyD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shebani Sethi, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford School of Medicine, Psychiatry and Behavioral Sciences
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31721257
Citation
Safer DL, Adler S, Dalai SS, Bentley JP, Toyama H, Pajarito S, Najarian T. A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa. Int J Eat Disord. 2020 Feb;53(2):266-277. doi: 10.1002/eat.23192. Epub 2019 Nov 13.
Results Reference
derived
PubMed Identifier
29038069
Citation
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.
Results Reference
derived
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