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This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa and binge eating disorder.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentermine/Topiramate-First | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of binge eating episodes as measured by the Eating Disorder Examination Assessment | The primary outcome is the frequency of binge episodes | 8.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of binge eating episodes measured by the Eating Disorder Examination Assessment | Frequency of binge episodes | 8.5 months |
| Percentage of Abstinence from Binge Eating as Measured by the Eating Disorder Examination Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra L Safer, MD | Stanford University | Principal Investigator |
| Sarah Adler, PsyD | Stanford University | Principal Investigator |
| Shebani Sethi, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford School of Medicine, Psychiatry and Behavioral Sciences | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31721257 | Derived | 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. | |
| 29038069 | Derived |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D010645 | Phentermine |
| C576188 | Qsymia |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Placebo | Drug | 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). |
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Percentage of patients who have had no binge episodes as assessed by the EDE
| 8.5 months |
| 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |