Binge Eating DisorderPhase 1NCT02553824
FDA Approved Medication to Reduce Binge Eating and/or Purging
A Phase 1 study testing Phentermine/Topiramate-First in people with Binge Eating Disorder and Bulimia Nervosa, run by Stanford University at 1 site in United States.
Trial summary
This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa and binge eating disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Binge Eating Disorder, Bulimia Nervosa
- What is being tested?
- Phentermine/Topiramate-First
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2015to 15 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford School of Medicine, Psychiatry and Behavioral Sciences
Stanford, California, 94305
About this study
Official title: Qsymia (Phentermine-topiramate) to Reduce Binge Eating/Purging in Patients With Bulimia Nervosa and Binge Eating Disorder
This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa and binge eating disorder.
Read the 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.
- Conditions
- Binge Eating Disorder, Bulimia Nervosa
- Being tested
- Phentermine/Topiramate-First, Placebo
- Keywords
- binge eating, bulimia nervosa, binge eating disorder, eating disorder treatment
- Medical subject headings
- Binge-Eating Disorder, Bulimia Nervosa, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentermine/Topiramate-FirstDrug
Also called Qsymia
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.
PlaceboDrug
Also called Placebo-First
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).
| Study group | Role | What they receive |
|---|---|---|
| Phentermine/Topiramate-First + Placebo | Experimental | 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 Receives: Drug: Phentermine/Topiramate-First; Drug: Placebo |
| Placebo-First + Phentermine/Topiramate | Placebo comparator | 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. Receives: Drug: Phentermine/Topiramate-First; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of binge eating episodes as measured by the Eating Disorder Examination Assessment
The primary outcome is the frequency of binge episodes
Measured: 8.5 months
Secondary outcomes (2)
Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment
Frequency of binge episodes
Measured: 8.5 months
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
Measured: 8.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start30 Oct 2015
- Primary completion23 Feb 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debra L. Safer, Stanford University
- Investigators
- Debra L Safer, MD, Principal investigator, Stanford UniversitySarah Adler, PsyD, Principal investigator, Stanford UniversityShebani Sethi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553824
- Sponsor's protocol ID
- 31390
- Status last verified
- May 2018
- First submitted
- 21 Aug 2015
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31721257Dalai 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.
PubMed 29038069
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qsymia (Phentermine-topiramate) to Reduce Binge Eating/Purging in Patients With Bulimia Nervosa and Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT02553824
- Acronym / sponsor ID
- 31390
- Conditions
- Binge Eating Disorder, Bulimia Nervosa
- Keywords
- binge eating, bulimia nervosa, binge eating disorder, eating disorder treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phentermine/Topiramate-First + Placebo | Experimental | Drug: Phentermine/Topiramate-First, Drug: PlaceboPatients 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 |
| Placebo-First + Phentermine/Topiramate | Placebo comparator | Drug: Phentermine/Topiramate-First, Drug: PlaceboPatients randomly assigned to this condition will receive the control medication (placebo) first followed by a 2 week washout, and then receive the study medication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phentermine/Topiramate-FirstAlso: QsymiaPatients 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. | Drug | Phentermine/Topiramate-First + Placebo, Placebo-First + Phentermine/Topiramate |
| PlaceboAlso: Placebo-FirstPatients 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). | Drug | Phentermine/Topiramate-First + Placebo, Placebo-First + Phentermine/Topiramate |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 31721257Safer 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.
- Derived from this study: PubMed 29038069Dalai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra L Safer, MD principal investigator
Stanford University
Sarah Adler, PsyD principal investigator
Stanford University
Shebani Sethi, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phentermine/Topiramate-First in people with Binge Eating Disorder and Bulimia Nervosa, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of binge eating episodes as measured by the Eating Disorder Examination Assessment (time frame: 8.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02553824, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.