Binge-Eating DisorderPhase 3NCT03926052
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment
A Phase 3 study testing Lisdexamfetamine Dimesylate in people with Binge-Eating Disorder and Obesity, run by Yale University at 1 site in United States.
Trial summary
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… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2019to 18 Nov 2024
- 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
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.
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. 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.
- Conditions
- Binge-Eating Disorder, Obesity
- Being tested
- Lisdexamfetamine Dimesylate, Placebo
- 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.
PlaceboDrug
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
| Study group | Role | What they receive |
|---|---|---|
| LDX | Active comparator | Not described Receives: Drug: Lisdexamfetamine Dimesylate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 month follow-up
Secondary outcomes (12)
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.
Measured: From baseline interview at study enrollment to 3 months after the 12-week treatment
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From post-treatment to the 12-month follow-up
Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Measured: 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.
Measured: From post-treatment to the 6-month follow-up
Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Measured: From post-treatment to the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start7 Aug 2019
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 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
- NCT03926052
- Sponsor's protocol ID
- 2000022480
- Other IDs
- 1R01DK114075-01A1
- Status last verified
- Nov 2025
- First submitted
- 18 Apr 2019
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. 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
- NCT03926052
- Acronym / sponsor ID
- 2000022480
- Conditions
- Binge-Eating Disorder, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDX | Active comparator | Drug: Lisdexamfetamine Dimesylate |
| Placebo | Placebo comparator | Drug: Placebo |
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 |
| PlaceboParticipants randomly assigned to this arm will receive 12 weeks of an inactive placebo. | Drug | Placebo |
Primary outcome
Binge-Eating Relapse
Time frame: 12 weeks
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.
Binge-Eating Relapse
Time frame: 6-month follow-up
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.
Binge-Eating Relapse
Time frame: 12 month follow-up
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 secondary outcomes
Change in Binge-Eating Frequency
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Change in Binge-Eating Frequency
Time frame: From post-treatment to the 6-month follow-up
Change in Binge-Eating Frequency
Time frame: From post-treatment to the 12-month follow-up
Change in Eating-Disorder Psychopathology (Continuous)
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Change in Eating-Disorder Psychopathology (Continuous)
Time frame: From post-treatment to the 6-month follow-up
Change in Eating-Disorder Psychopathology (Continuous)
Time frame: From post-treatment to the 12-month follow-up
Change in Depressive Symptoms
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Change in Depressive Symptoms
Time frame: From post-treatment to the 6-month follow-up
Change in Depressive Symptoms
Time frame: From post-treatment to the 12-month follow-up
Percent Change in Weight
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Percent Change in Weight
Time frame: From post-treatment to the 6-month follow-up
Percent Change in Weight
Time frame: From post-treatment to the 12-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 Dec 2025. 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. Some participants in this study may receive a placebo. 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 Dec 2025). 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 Relapse (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.