Binge Eating DisorderPhase 2NCT02659475
Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED)
A Phase 2 study testing PHEN/TPM ER (Qsymia®) in people with Binge Eating Disorder, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
The goal of this project is to evaluate the effectiveness and tolerability of the novel weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle modification counseling in the treatment of binge eating disorder (BED) in overweight or obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- PHEN/TPM ER (Qsymia®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, ages of 18- 65 years, inclusive.
- Subjects will meet DSM-5 criteria for a diagnosis of BED. These are:
- Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
- Eating, in a discrete period of time (e.g., within a 2 hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and
- Sense of lack of control over the eating (e.g., a feeling that one cannot stop eating or control what or how much one is eating)
- The binge eating episodes are associated with at least three of the following:
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- eating much more rapidly than normal
- eating until uncomfortably full
- eating large amounts of food when not feeling physically hungry
- eating alone because of being embarrassed by how much one is eating
- feeling disgusted with oneself, depressed, or feeling very guilty after overeating
- Marked distress regarding binge eating is present
- The binge eating occurs, on average, at least once a week for 3 months
- The binge eating is not associated with the recurrent use of inappropriate compensatory behavior as in bulimia nervosa and does not occur exclusively during the course of bulimia nervosa or anorexia nervosa
- Subjects will be obese (defined as a BMI ≥ 30 mg/kg2) or overweight (defined as BMI ≥ 27 kg/m2 or greater) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
- Subjects in treatment for a weight-related comorbidity (hypertension, type 2 diabetes mellitus, and/or dyslipidemia), must be on a stable medication regimen, defined as being on current dose of medication for at least 3 months prior to study enrollment.
Who cannot join
- Current bulimia nervosa or anorexia nervosa.
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered to be adequate methods of birth control: 1. Intrauterine device (IUD); 2. Barrier protection; 3. A contraceptive implantation system (Norplant); 4. Oral contraceptive pills; 5. A surgically sterile partner; and 6. Abstinence. Women who are >2years post-menopausal or surgically-sterile are not considered of childbearing potential. All female subjects will have a negative pregnancy test prior to randomization.
- Subjects who are displaying clinically significant suicidality operationalized as a score ≥ 2 on item 9 of the Beck Depression Inventory (BDI) (21), or suicidal ideation on the Columbia-Suicide Severity Scale (C-SSRS) (22), or homicidality.
- Subjects who are receiving a psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED or weight management that was begun within the 3 months before study entry. Subjects who are receiving psychotherapy that was initiated prior to 3 months of the beginning of the study will be allowed to continue to receive their psychotherapy during the trial only if they agree to not make any changes in the frequency or nature of their psychotherapy during the course of the drug trial.
- A DSM-5 diagnosis of a substance-related or addictive disorder (except a tobacco-related disorder) within the 6 months prior to enrollment.
- A lifetime DSM-5 history of psychosis, mania or hypomania, or dementia.
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- History of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance.
- Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.
- Have a history of a structural cardiac abnormality, valvular cardiac disease, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problem.
- History of seizure disorder, including clinically-significant febrile seizures in childhood.
- Subjects with glaucoma or hyperthyroidism.
- Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation.
- Have clinically relevant abnormal laboratory results.
- Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes anti-obesity drugs, psychostimulants, wake-promoting agents, drugs with serotonergic properties, antidepressants, and antipsychotics.
- Subjects who have received any psychotropic medications (other than hypnotics) within four weeks prior to randomization, including monoamine oxidase inhibitors, tricyclics, selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, or psychostimulants.
- Subjects who have received investigational medications or depot neuroleptics within three months prior to randomization.
- Subjects who have a known allergy to PHEN/TPM ER (Qsymia®) or its constituents.
- Subjects with a urine drug screen positive for a drug that, in the opinion of the investigator, is being abused.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Phentermine/Topiramate Extended Release (PHEN/TPM ER; Qsymia®) in Ten Subjects With Overweight or Obesity and DSM-V Binge Eating Disorder (BED)
The goal of this project is to evaluate the effectiveness and tolerability of the novel weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle modification counseling in the treatment of binge eating disorder (BED) in overweight or obese individuals.
Read the detailed description
This is an exploratory open-label trial of PHEN/TPM ER (Qsymia®) in BED. It is hypothesized that PHEN/TPM ER (Qsymia®) will be an effective, safe, and well tolerated treatment for BED and propose to conduct a 1-site, 12-week, open-label, flexible dose study of PHEN/TPM ER (Qsymia®) in 10 outpatients, ages 18 through 65 years, with BED. It is also hypothesized that PHEN/TPM ER (Qsymia®) will reduce weight and binge eating behavior, and will be well tolerated. The primary objective is to show that PHEN/TPM ER (Qsymia®) along with nutritional and lifestyle modification counseling is effective in reducing weight in overweight or obese patients with BED. Secondary objectives are to show that PHEN/TPM ER (Qsymia®) is effective in reducing frequency of binge eating episodes and associated eating psychopathology and is safe and well tolerated in patients with BED.
- Conditions
- Binge Eating Disorder
- Being tested
- PHEN/TPM ER (Qsymia®)
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHEN/TPM ER (Qsymia®)Drug
PHEN/TPM ER (Qsymia®)
| Study group | Role | What they receive |
|---|---|---|
| PHEN/TPM ER (Qsymia®) | Experimental | PHEN/TPM ER (Qsymia®) Receives: Drug: PHEN/TPM ER (Qsymia®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight
Weight will be measured at all study visits - screen, baseline (week 0), and weeks 2, 4, 6, 8, 10. 12
Measured: from baseline visit (week 0) to final visit or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Anna Guerdjikova, PhD,LISW, Principal investigator, Lindner Center of HOPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659475
- Sponsor's protocol ID
- 2015-2630
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Guerdjikova AI, Williams S, Blom TJ, Mori N, McElroy SL. Combination Phentermine-Topiramate Extended Release for the Treatment of Binge Eating Disorder: An Open-Label, Prospective Study. Innov Clin Neurosci. 2018 Jun 1;15(5-6):17-21.
PubMed 30013815
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phentermine/Topiramate Extended Release (PHEN/TPM ER; Qsymia®) in Ten Subjects With Overweight or Obesity and DSM-V Binge Eating Disorder (BED)
- ClinicalTrials.gov ID
- NCT02659475
- Acronym / sponsor ID
- 2015-2630
- Conditions
- Binge Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Jan 2016 (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.
The goal of this project is to evaluate the effectiveness and tolerability of the novel weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle modification counseling in the treatment of binge eating disorder (BED) in overweight or obese individuals.
Detailed description
This is an exploratory open-label trial of PHEN/TPM ER (Qsymia®) in BED. It is hypothesized that PHEN/TPM ER (Qsymia®) will be an effective, safe, and well tolerated treatment for BED and propose to conduct a 1-site, 12-week, open-label, flexible dose study of PHEN/TPM ER (Qsymia®) in 10 outpatients, ages 18 through 65 years, with BED. It is also hypothesized that PHEN/TPM ER (Qsymia®) will reduce weight and binge eating behavior, and will be well tolerated. The primary objective is to show that PHEN/TPM ER (Qsymia®) along with nutritional and lifestyle modification counseling is effective in reducing weight in overweight or obese patients with BED. Secondary objectives are to show that PHEN/TPM ER (Qsymia®) is effective in reducing frequency of binge eating episodes and associated eating psychopathology and is safe and well tolerated in patients with BED.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHEN/TPM ER (Qsymia®) | Experimental | Drug: PHEN/TPM ER (Qsymia®)PHEN/TPM ER (Qsymia®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men and women, ages of 18- 65 years, inclusive.
- Subjects will meet DSM-5 criteria for a diagnosis of BED. These are:
- Subjects will be obese (defined as a BMI ≥ 30 mg/kg2) or overweight (defined as BMI ≥ 27 kg/m2 or greater) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
- Subjects in treatment for a weight-related comorbidity (hypertension, type 2 diabetes mellitus, and/or dyslipidemia), must be on a stable medication regimen, defined as being on current dose of medication for at least 3 months prior to study enrollment.
Key exclusion criteria (18 listed)
- Current bulimia nervosa or anorexia nervosa.
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered to be adequate methods of birth control: 1. Intrauterine device (IUD); 2. Barrier protection; 3. A contraceptive implantation system (Norplant); 4. Oral contraceptive pills; 5. A surgically sterile partner; and 6. Abstinence. Women who are >2years post-menopausal or surgically-sterile are not considered of childbearing potential. All female subjects will have a negative pregnancy test prior to randomization.
- Subjects who are displaying clinically significant suicidality operationalized as a score ≥ 2 on item 9 of the Beck Depression Inventory (BDI) (21), or suicidal ideation on the Columbia-Suicide Severity Scale (C-SSRS) (22), or homicidality.
- Subjects who are receiving a psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED or weight management that was begun within the 3 months before study entry. Subjects who are receiving psychotherapy that was initiated prior to 3 months of the beginning of the study will be allowed to continue to receive their psychotherapy during the trial only if they agree to not make any changes in the frequency or nature of their psychotherapy during the course of the drug trial.
- A DSM-5 diagnosis of a substance-related or addictive disorder (except a tobacco-related disorder) within the 6 months prior to enrollment.
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 |
|---|---|---|
| PHEN/TPM ER (Qsymia®)PHEN/TPM ER (Qsymia®) | Drug | PHEN/TPM ER (Qsymia®) |
Primary outcome
change in weight
Time frame: from baseline visit (week 0) to final visit or early termination
Weight will be measured at all study visits - screen, baseline (week 0), and weeks 2, 4, 6, 8, 10. 12
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 20 Sep 2016.
- Derived from this study: PubMed 30013815Guerdjikova AI, Williams S, Blom TJ, Mori N, McElroy SL. Combination Phentermine-Topiramate Extended Release for the Treatment of Binge Eating Disorder: An Open-Label, Prospective Study. Innov Clin Neurosci. 2018 Jun 1;15(5-6):17-21.
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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.
Anna Guerdjikova, PhD,LISW principal investigator
Lindner Center of HOPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PHEN/TPM ER (Qsymia®) in people with Binge Eating Disorder, run by Lindner Center of HOPE 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 16 inclusion and 18 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 20 Sep 2016. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change in weight (time frame: from baseline visit (week 0) to final visit or early termination). 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 NCT02659475, which also lists 1 linked publication.
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 20 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.