Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Binge-Eating Disorder
• Intervention / Treatment: Drug: Lisdexamfetamine Dimesylate; Drug: 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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Active Comparator: LDX	Drug: Lisdexamfetamine Dimesylate; Participants randomly assigned to this arm will receive 12 weeks of LDX medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	From baseline interview at study enrollment to 3 months after the 12-week treatment
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.	From post-treatment to the 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.	From post-treatment to the 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Body Mass Index (BMI)	BMI is calculated using measured height and weight (e.g., percent loss)	From baseline interview at study enrollment to 3 months after the 12-week treatment
Body Mass Index (BMI)	BMI is calculated using measured height and weight (e.g., percent loss)	From post-treatment to the 6-month follow-up
Body Mass Index (BMI)	BMI is calculated using measured height and weight (e.g., percent loss)	From post-treatment to the 12-month follow-up

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Carlos M Grilo, Ph.D., Yale University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperphagia; Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: 2000022480; 1R01DK114075-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No