Binge-Eating DisorderPhase 3NCT03924193
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
A Phase 3 study testing Lisdexamfetamine Dimesylate, Cognitive-Behavioral Therapy and Combination LDX and Cognitive-Behavioral Therapy in people with Binge-Eating Disorder and Obesity, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Binge-Eating Disorder, Obesity
- What is being tested?
- Lisdexamfetamine Dimesylate, Cognitive-Behavioral Therapy and Combination LDX and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 13 Sep 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 64 years old
- Meets DSM-5 criteria for binge-eating disorder
- BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50
- Medically cleared as determined by EKG and medical record review
- Available for the duration of the treatment and follow-up (18 months)
- Read, comprehend, and write English at a sufficient level to complete study-related materials
- Able to travel to study location (New Haven, CT) for weekly visits
Who cannot join
- Previous history of problems with LDX or other stimulants
- Current psychostimulant use or use of any medication for ADHD
- Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
- History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.
- History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.
- Current uncontrolled hypertension
Show all 22Show fewer
- Current uncontrolled type I or II diabetes mellitus
- Current uncontrolled thyroid illness
- Gallbladder disease
- Co-occurring severe mental illness requiring hospitalization or intensive treatment
- Endorses current active suicidal or homicidal ideation with intent or plan
- History or current alcohol or substance use disorder (smoking is not exclusionary)
- Predisposition to seizures
- History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting
- Currently taking MAOI, SSRI or strong inhibitors of CYP2D6
- History of allergy or sensitivity to the study medication or stimulant medications
- Current use of medications contraindicated with the study medications
- Currently breast feeding or pregnant, or not willing to use reliable form of contraception
- Currently taking opioid pain medications or drugs
- Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss
- Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device
- Medical status judged by study physician as contraindication
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Department of Psychiatry
New Haven, Connecticut, 06510
About this study
Official title: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity
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.
Read the detailed description
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.
- Conditions
- Binge-Eating Disorder, Obesity
- Being tested
- Lisdexamfetamine Dimesylate, Cognitive-Behavioral Therapy, Combination LDX and Cognitive-Behavioral Therapy
- Medical subject headings
- Binge-Eating Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisdexamfetamine DimesylateDrug
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
Cognitive-Behavioral TherapyBehavioural
Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
Combination LDX and Cognitive-Behavioral TherapyOther
Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
| Study group | Role | What they receive |
|---|---|---|
| LDX | Active comparator | Not described Receives: Drug: Lisdexamfetamine Dimesylate |
| Cognitive-Behavioral Therapy | Active comparator | Not described Receives: Behavioral: Cognitive-Behavioral Therapy |
| LDX and Cognitive Behavioral Therapy | Active comparator | Not described Receives: Other: Combination LDX and Cognitive-Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Post-treatment (3 months)
Secondary outcomes (3)
Binge-Eating Remission
Categorical: zero binges/28 days
Measured: 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).
Measured: 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).
Measured: Post-treatment (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start25 Mar 2019
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos M Grilo, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924193
- Sponsor's protocol ID
- 2000022480_b
- Other IDs
- 1R01DK114075-01A1
- Status last verified
- Oct 2024
- First submitted
- 17 Apr 2019
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Aug;59(8):1838-1846. doi: 10.1002/eat.70115. Epub 2026 Apr 29.
PubMed 42057441Grilo CM, Ivezaj V, Yurkow S, Tek C, Gueorguieva R. Cognitive-Behavioral Therapy and Lisdexamfetamine, Alone and Combined, for Binge-Eating Disorder: Secondary Outcomes of a Randomized Controlled Trial. Int J Eat Disord. 2025 Oct;58(10):1970-1978. doi: 10.1002/eat.24502. Epub 2025 Jul 9.
PubMed 40631364Yurkow 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.
PubMed 40338285
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity
- ClinicalTrials.gov ID
- NCT03924193
- Acronym / sponsor ID
- 2000022480_b
- Conditions
- Binge-Eating Disorder, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LDX | Active comparator | Drug: Lisdexamfetamine Dimesylate |
| Cognitive-Behavioral Therapy | Active comparator | Behavioral: Cognitive-Behavioral Therapy |
| LDX and Cognitive Behavioral Therapy | Active comparator | Other: Combination LDX and Cognitive-Behavioral Therapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 to 64 years old
- Meets DSM-5 criteria for binge-eating disorder
- BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50
- Medically cleared as determined by EKG and medical record review
- Available for the duration of the treatment and follow-up (18 months)
Key exclusion criteria (22 listed)
- Previous history of problems with LDX or other stimulants
- Current psychostimulant use or use of any medication for ADHD
- Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
- History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.
- History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lisdexamfetamine DimesylateParticipants randomly assigned to this arm will receive 12 weeks of LDX medication. | Drug | LDX |
| Cognitive-Behavioral TherapyParticipants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy | Behavioural | Cognitive-Behavioral Therapy |
| Combination LDX and Cognitive-Behavioral TherapyParticipants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy | Other | LDX and Cognitive Behavioral Therapy |
Primary outcome
Binge-Eating Frequency
Time frame: Post-treatment (3 months)
Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
Body Mass Index
Time frame: Post-treatment (3 months)
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.
3 secondary outcomes
Binge-Eating Remission
Time frame: Post-treatment (3 months)
Eating-Disorder Psychopathology
Time frame: Post-treatment (3 months)
Depressive Symptoms
Time frame: Post-treatment (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42057441Yurkow 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 Aug;59(8):1838-1846. doi: 10.1002/eat.70115. Epub 2026 Apr 29.
- Derived from this study: PubMed 40631364Grilo CM, Ivezaj V, Yurkow S, Tek C, Gueorguieva R. Cognitive-Behavioral Therapy and Lisdexamfetamine, Alone and Combined, for Binge-Eating Disorder: Secondary Outcomes of a Randomized Controlled Trial. Int J Eat Disord. 2025 Oct;58(10):1970-1978. doi: 10.1002/eat.24502. Epub 2025 Jul 9.
- Derived from this study: PubMed 40338285Yurkow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos M Grilo, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lisdexamfetamine Dimesylate, Cognitive-Behavioral Therapy and Combination LDX and Cognitive-Behavioral Therapy in people with Binge-Eating Disorder and Obesity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge-Eating Frequency (time frame: Post-treatment (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924193, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.