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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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Brief Summary: This study will compare the effectiveness of cognitive behavioral therapy (CBT), lisdexamfetamine (LDX), and the combination of CBT and LDX for the treatment of binge-eating disorder in patients with obesity. This is an acute treatment comparing CBT or LDX alone or in combination.
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. This study examined the effectiveness of two leading but distinct treatments - lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) - alone and in combination, for BED in patients with obesity. LDX is the first and only FDA-approved medication for the treatment of BED and has demonstrated short-term effectiveness relative to placebo. CBT is the best-established psychological treatment, has demonstrated short-term effectiveness and "treatment specificity" (i.e., superiority to a variety of control and active treatments), has shown longer-term superiority to fluoxetine, and longer-term durability of outcomes. N=180 participants with BED and obesity will be randomly assigned to one of three interventions, CBT alone, LDX alone, or CBT combined with LDX. This RCT will provide new findings regarding the relative effectiveness of LDX, CBT, and combined CBT+LDX for patients with obesity and BED. No such study has been performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDX | Active Comparator |
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| Cognitive-Behavioral Therapy | Active Comparator |
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| LDX and Cognitive Behavioral Therapy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Drug | Participants randomly assigned to this arm will receive 12 weeks of LDX medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Binge-Eating Frequency | Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally). | Post-treatment (3 months) |
| Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss). We note that % BMI change and % Weight Loss are exactly the same (when height is kept constant, which was the case with this short-term study with adults). Negative values indicate weight loss and positive values indicate weight gain. | Post-treatment (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Binge-Eating Remission | Categorical: zero binges/28 days | Post-treatment (3 months) |
| Eating-Disorder Psychopathology | 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). |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42057441 | Derived | Yurkow S, Bowman WP, Ivezaj V, Grilo CM. Examining Heterogeneity of Patient Outcomes in a Randomized Controlled Trial for Binge-Eating Disorder Testing Cognitive-Behavioral Therapy and Lisdexamfetamine, Alone and Combined. Int J Eat Disord. 2026 Apr 29:10.1002/eat.70115. doi: 10.1002/eat.70115. Online ahead of print. | |
| 40338285 | Derived | Yurkow S, Ivezaj V, Pittman B, Grilo CM. Preferences for Lisdexamfetamine vs Cognitive-Behavioral Therapy for Binge-Eating Disorder: Correlates and Outcomes. J Clin Psychiatry. 2025 May 7;86(2):24m15552. doi: 10.4088/JCP.24m15552. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lisdexamfetamine Dimesylate (LDX) | Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. |
| FG001 | Cognitive-Behavioral Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 13, 2022 |
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| Cognitive-Behavioral Therapy | Behavioral | Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy |
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| Combination LDX and Cognitive-Behavioral Therapy | Other | Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy |
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| Post-treatment (3 months) |
| 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). | Post-treatment (3 months) |
Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
| FG002 | LDX and Cognitive Behavioral Therapy | Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lisdexamfetamine Dimesylate (LDX) | Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. |
| BG001 | Cognitive-Behavioral Therapy | Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy |
| BG002 | LDX and Cognitive Behavioral Therapy | Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Frequency | Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally). | Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point. | Posted | Mean | Standard Deviation | Binge-eating episodes (past 28 days) | Post-treatment (3 months) |
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| Primary | Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss). We note that % BMI change and % Weight Loss are exactly the same (when height is kept constant, which was the case with this short-term study with adults). Negative values indicate weight loss and positive values indicate weight gain. | Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point. | Posted | Mean | Standard Deviation | percentage of change in weight | Post-treatment (3 months) |
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| Secondary | Binge-Eating Remission | Categorical: zero binges/28 days | Posted | Count of Participants | Participants | Post-treatment (3 months) |
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| Secondary | Eating-Disorder Psychopathology | 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). | Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point. | Posted | Mean | Standard Deviation | scores on a scale ranging from 0-6 | Post-treatment (3 months) |
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| Secondary | 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). | Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point. | Posted | Mean | Standard Deviation | scores on a scale ranging from 0-63 | Post-treatment (3 months) |
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Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
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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 | Lisdexamfetamine Dimesylate (LDX) | Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. | 0 | 47 | 1 | 47 | 46 | 47 |
| EG001 | Cognitive-Behavioral Therapy | Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy | 0 | 47 | 0 | 47 | 0 | 0 |
| EG002 | LDX and Cognitive Behavioral Therapy | Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy | 0 | 47 | 0 | 47 | 46 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruxism | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Increased Energy | General disorders | Systematic Assessment |
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| Feeling Jittery | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Increased Heart Rate | Nervous system disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Itchy Skin | General disorders | Systematic Assessment |
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| Excessive Sweating | Nervous system disorders | Systematic Assessment |
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| Tingling Sensation | Nervous system disorders | Systematic Assessment |
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| Racing Thoughts | Psychiatric disorders | Systematic Assessment |
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| Nightmare | General disorders | Systematic Assessment |
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| Mouth/throat Pain | General disorders | Systematic Assessment |
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| Changes to Thought Patterns | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Valentina Ivezaj | Yale University School of Medicine | 2037857807 | valentina.ivezaj@yale.edu |
| Sep 11, 2024 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2022 | Feb 23, 2024 | ICF_001.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 |
| 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 |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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