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

Primary Purpose

Binge-Eating Disorder, Obesity

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lisdexamfetamine Dimesylate
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Department of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LDX

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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).
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).
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).
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).
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).
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).
Body Mass Index (BMI)
BMI is calculated using measured height and weight (e.g., percent loss)
Body Mass Index (BMI)
BMI is calculated using measured height and weight (e.g., percent loss)
Body Mass Index (BMI)
BMI is calculated using measured height and weight (e.g., percent loss)

Full Information

First Posted
April 18, 2019
Last Updated
March 8, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03926052
Brief Title
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment
Official Title
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LDX
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine Dimesylate
Intervention Description
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Primary Outcome Measure Information:
Title
Binge-Eating Relapse
Description
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.
Time Frame
From baseline interview at study enrollment to 3 months after the 12-week treatment
Title
Binge-Eating Relapse
Description
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.
Time Frame
From post-treatment to the 6-month follow-up
Title
Binge-Eating Relapse
Description
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.
Time Frame
From post-treatment to the 12-month follow-up
Secondary Outcome Measure Information:
Title
Binge-Eating Frequency
Description
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.
Time Frame
From baseline interview at study enrollment to 3 months after the 12-week treatment
Title
Binge-Eating Frequency
Description
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.
Time Frame
From post-treatment to the 6-month follow-up
Title
Binge-Eating Frequency
Description
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.
Time Frame
From post-treatment to the 12-month follow-up
Title
Eating-Disorder Psychopathology (Continuous)
Description
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).
Time Frame
From baseline interview at study enrollment to 3 months after the 12-week treatment
Title
Eating-Disorder Psychopathology (Continuous)
Description
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).
Time Frame
From post-treatment to the 6-month follow-up
Title
Eating-Disorder Psychopathology (Continuous)
Description
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).
Time Frame
From post-treatment to the 12-month follow-up
Title
Depressive Symptoms
Description
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).
Time Frame
From baseline interview at study enrollment to 3 months after the 12-week treatment
Title
Depressive Symptoms
Description
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).
Time Frame
From post-treatment to the 6-month follow-up
Title
Depressive Symptoms
Description
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).
Time Frame
From post-treatment to the 12-month follow-up
Title
Body Mass Index (BMI)
Description
BMI is calculated using measured height and weight (e.g., percent loss)
Time Frame
From baseline interview at study enrollment to 3 months after the 12-week treatment
Title
Body Mass Index (BMI)
Description
BMI is calculated using measured height and weight (e.g., percent loss)
Time Frame
From post-treatment to the 6-month follow-up
Title
Body Mass Index (BMI)
Description
BMI is calculated using measured height and weight (e.g., percent loss)
Time Frame
From post-treatment to the 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Ivezaj, Ph.D.
Phone
203-785-7210
Email
valentina.ivezaj@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos M Grilo, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Department of Psychiatry
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Ivezaj, Ph.D.
Phone
203-785-7210
Email
valentina.ivezaj@yale.edu
First Name & Middle Initial & Last Name & Degree
Carlos M Grilo, Ph.D.

12. IPD Sharing Statement

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

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