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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK126637-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine dimesylate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (Medication) | Drug | Medication will be taken daily in pill form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loss-of-Control Eating Frequency | Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month. | From baseline interview at study enrollment to after the 12-week treatment |
| Loss-of-Control Eating Frequency | Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month. | From post-treatment to the 6-month follow-up |
| Loss-of-Control Eating Frequency | Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month. | From post-treatment to the 12-month follow-up |
| Body Mass Index (BMI) | BMI is calculated using measured height and weight | From baseline at study enrollment to after the 12-week treatment |
| Body Mass Index (BMI) | BMI is calculated using measured height and weight | From post-treatment to the 6-month follow-up |
| Body Mass Index (BMI) | BMI is calculated using measured height and weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Grilo, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06519 | United States |
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| Placebo | Other | Placebo will be inactive and taken daily in pill form. |
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| From post-treatment to the 12-month follow-up |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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