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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03926052

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted January 14, 2021

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.

  • Condition or Disease:Binge-Eating Disorder
    Obesity
  • Intervention/Treatment: Drug: Lisdexamfetamine Dimesylate
    Drug: Placebo
  • Phase: Phase 3
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
  • Study Type: Interventional
  • Estimated Enrollment: 80 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: July 2024
  • Estimated Study Completion Date: July 2024
Arms and interventions
Arm Intervention/treatment
Active Comparator: LDX
Drug: Lisdexamfetamine Dimesylate
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
Placebo Comparator: Placebo
Drug: Placebo
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Outcome Measures
  • Primary Outcome Measures: 1. Binge-Eating Relapse [ Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment ]
    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.
  • 2. Binge-Eating Relapse [ Time Frame: From post-treatment to the 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.
  • 3. Binge-Eating Relapse [ Time Frame: From post-treatment to the 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.
  • Secondary Outcome Measures: 1. Binge-Eating Frequency [ Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment ]
    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.
  • 2. Binge-Eating Frequency [ Time Frame: From post-treatment to the 6-month follow-up ]
    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.
  • 3. Binge-Eating Frequency [ Time Frame: From post-treatment to the 12-month follow-up ]
    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.
  • 4. Eating-Disorder Psychopathology (Continuous) [ Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment ]
    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).
  • 5. Eating-Disorder Psychopathology (Continuous) [ Time Frame: From post-treatment to the 6-month follow-up ]
    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).
  • 6. Eating-Disorder Psychopathology (Continuous) [ Time Frame: From post-treatment to the 12-month follow-up ]
    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).
  • 7. Depressive Symptoms [ Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment ]
    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).
  • 8. Depressive Symptoms [ Time Frame: From post-treatment to the 6-month follow-up ]
    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).
  • 9. Depressive Symptoms [ Time Frame: From post-treatment to the 12-month follow-up ]
    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).
  • 10. Body Mass Index (BMI) [ Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment ]
    BMI is calculated using measured height and weight (e.g., percent loss)
  • 11. Body Mass Index (BMI) [ Time Frame: From post-treatment to the 6-month follow-up ]
    BMI is calculated using measured height and weight (e.g., percent loss)
  • 12. Body Mass Index (BMI) [ Time Frame: From post-treatment to the 12-month follow-up ]
    BMI is calculated using measured height and weight (e.g., percent loss)
Eligibility Criteria
  • Ages Eligible for Study: 18 to 64 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Valentina Ivezaj, Ph.D. 203-785-7210 valentina.ivezaj@yale.edu

Locations

United States, Connecticut
Yale Department of Psychiatry
New Haven

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Carlos M Grilo, Ph.D. Yale University

More Information
  • Responsible Party: Yale University
  • ClinicalTrials.gov Identifier: NCT03926052 History of Changes
  • Other Study ID Numbers: 2000022480
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: January 14, 2021
  • Last Verified: January 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Bulimia
    Obesity
    Feeding and Eating Disorders
    Binge-Eating Disorder