Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
2 other identifiers
interventional
141
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2019
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
April 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2023
CompletedResults Posted
Study results publicly available
October 17, 2024
CompletedOctober 17, 2024
October 1, 2024
4.5 years
April 17, 2019
September 11, 2024
October 15, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Secondary Outcomes (3)
Binge-Eating Remission
Post-treatment (3 months)
Eating-Disorder Psychopathology
Post-treatment (3 months)
Depressive Symptoms
Post-treatment (3 months)
Study Arms (3)
LDX
ACTIVE COMPARATORCognitive-Behavioral Therapy
ACTIVE COMPARATORLDX and Cognitive Behavioral Therapy
ACTIVE COMPARATORInterventions
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale Department of Psychiatry
New Haven, Connecticut, 06510, United States
Related Publications (1)
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.
PMID: 40338285DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Valentina Ivezaj
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos M Grilo, Ph.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2019
First Posted
April 23, 2019
Study Start
March 25, 2019
Primary Completion
September 13, 2023
Study Completion
September 13, 2023
Last Updated
October 17, 2024
Results First Posted
October 17, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share