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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK114075-01A1 | 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 (LDX) medication as a maintenance therapy for the treatment of binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, LDX medication results in superior maintenance and longer-term outcomes compared with placebo.
Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide findings from a controlled test, amongst responders to acute treatments, whether LDX medication results in superior maintenance and longer-term outcomes than placebo. This is one of the few RCTs for BED of medication with follow-up after medication discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDX | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Drug | Participants randomly assigned to this arm will receive 12 weeks of LDX medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binge-Eating Relapse | Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month. | 12 weeks |
| Binge-Eating Relapse | Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month. | 6-month follow-up |
| Binge-Eating Relapse | Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month. | 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month. | From baseline interview at study enrollment to 3 months after the 12-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Department of Psychiatry | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LDX (Lisdexamfetamine Dimesylate) | Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. |
| FG001 | Placebo | Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LDX (Lisdexamfetamine Dimesylate) | Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. |
| BG001 | Placebo | Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Binge-Eating Relapse | Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month. | Posted | Count of Participants | Participants | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LDX (Lisdexamfetamine Dimesylate) | Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Grilo | Yale University School of Medicine | 2037857210 | carlos.grilo@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2022 | Sep 18, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2022 | Feb 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| Placebo | Drug | Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. |
|
| Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month. | From post-treatment to the 6-month follow-up |
| Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month. | From post-treatment to the 12-month follow-up |
| Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | From baseline interview at study enrollment to 3 months after the 12-week treatment |
| Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | From post-treatment to the 6-month follow-up |
| Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | From post-treatment to the 12-month follow-up |
| Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | From baseline interview at study enrollment to 3 months after the 12-week treatment |
| Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | From post-treatment to the 6-month follow-up |
| Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | From post-treatment to the 12-month follow-up |
| Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | From baseline interview at study enrollment to 3 months after the 12-week treatment |
| Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | From post-treatment to the 6-month follow-up |
| Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | From post-treatment to the 12-month follow-up |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Binge-Eating Relapse | Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month. | Posted | Count of Participants | Participants | 6-month follow-up |
|
|
|
| Primary | Binge-Eating Relapse | Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month. | Posted | Count of Participants | Participants | 12 month follow-up |
|
|
|
| Secondary | Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month. | Posted | Mean | Standard Deviation | episodes per the past 28 days | From baseline interview at study enrollment to 3 months after the 12-week treatment |
|
|
|
| Secondary | Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month. | Posted | Mean | Standard Deviation | episodes per the past 28 days | From post-treatment to the 6-month follow-up |
|
|
|
| Secondary | Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month. | Posted | Mean | Standard Deviation | episodes per the past 28 days | From post-treatment to the 12-month follow-up |
|
|
|
| Secondary | Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | Posted | Mean | Standard Deviation | score on a scale | From baseline interview at study enrollment to 3 months after the 12-week treatment |
|
|
|
| Secondary | Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 6-month follow-up |
|
|
|
| Secondary | Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 12-month follow-up |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | Posted | Mean | Standard Deviation | score on a scale | From baseline interview at study enrollment to 3 months after the 12-week treatment |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 6-month follow-up |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 12-month follow-up |
|
|
|
| Secondary | Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | Posted | Mean | Standard Deviation | percent change | From baseline interview at study enrollment to 3 months after the 12-week treatment |
|
|
|
| Secondary | Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | Posted | Mean | Standard Deviation | percent change | From post-treatment to the 6-month follow-up |
|
|
|
| Secondary | Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | Posted | Mean | Standard Deviation | percent change | From post-treatment to the 12-month follow-up |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 13 |
| 32 |
| EG001 | Placebo | Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. | 0 | 29 | 0 | 29 | 6 | 29 |
| Dry mouth | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Increased energy | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Feeling jittery | General disorders | Systematic Assessment |
|
| Increased heart rate | Nervous system disorders | Systematic Assessment |
|
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |