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| Name | Class |
|---|---|
| Cephalon | INDUSTRY |
| University of Cincinnati | OTHER |
The purpose of this research study is to study the effectiveness, tolerability and safety of armodafinil in outpatients with binge eating disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Armodafinil | Experimental | Flexible dose 150-250mg/day |
|
| Mathing Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armodafinil | Drug | flexible dose 150-250mg/day |
| |
| Armodafinil |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is binge day frequency as assessed by take-home patient diary | 12 treatment weeks |
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Inclusion Criteria:
Inclusion Criteria: Criteria for entering this study will include all of the following:
Subjects will meet the DSM-IV-TR criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV-TR criteria are as follows:
In addition, subjects will report at least 3 binge eating days per week for the 2 weeks prior to randomization prospectively documented in take-home binge diaries. A binge eating day (or binge day) is a day during which at least one binge eating episode occurs.
Subjects will have a BMI ≥ 25. The subject population is expected to include overweight and obese individuals.
Men or women, through the ages of 18 and 65 years, inclusive.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindner Center of HOPE | Mason | Ohio | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26011779 | Derived | McElroy SL, Guerdjikova AI, Mori N, Blom TJ, Williams S, Casuto LS, Keck PE Jr. Armodafinil in binge eating disorder: a randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jul;30(4):209-15. doi: 10.1097/YIC.0000000000000079. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2016 | |
| Reset | Feb 17, 2016 | |
| Release | Mar 25, 2019 | |
| Reset | Apr 15, 2019 | |
| Release | Oct 14, 2020 | |
| Reset | Nov 4, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2016 | Feb 17, 2016 | |||
| Mar 25, 2019 |
| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
150-250mg/day; flexible dose |
|
| Matching placebo | Drug | Placebo comparator |
|
| Apr 15, 2019 |
| Oct 14, 2020 | Nov 4, 2020 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |