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出境医 / 临床实验 / Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Obesity Drug: Lisdexamfetamine Dimesylate Behavioral: Cognitive-Behavioral Therapy Other: Combination LDX and Cognitive-Behavioral Therapy 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. This study examined the effectiveness of two leading but distinct treatments - lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) - alone and in combination, for BED in patients with obesity. LDX is the first and only FDA-approved medication for the treatment of BED and has demonstrated short-term effectiveness relative to placebo. CBT is the best-established psychological treatment, has demonstrated short-term effectiveness and "treatment specificity" (i.e., superiority to a variety of control and active treatments), has shown longer-term superiority to fluoxetine, and longer-term durability of outcomes. N=180 participants with BED and obesity will be randomly assigned to one of three interventions, CBT alone, LDX alone, or CBT combined with LDX. This RCT will provide new findings regarding the relative effectiveness of LDX, CBT, and combined CBT+LDX for patients with obesity and BED. No such study has been performed.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity
Actual Study Start Date : March 25, 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.
Active Comparator: Cognitive-Behavioral Therapy Behavioral: Cognitive-Behavioral Therapy
Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
Active Comparator: LDX and Cognitive Behavioral Therapy Other: Combination LDX and Cognitive-Behavioral Therapy
Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
Outcome Measures
Primary Outcome Measures :
  1. Binge-Eating Frequency [ Time Frame: Post-treatment (3 months) ]
    Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).

  2. Body Mass Index [ Time Frame: Post-treatment (3 months) ]
    BMI is calculated using measured height and weight (e.g., percent loss).


Secondary Outcome Measures :
  1. Binge-Eating Remission [ Time Frame: Post-treatment (3 months) ]
    Categorical: zero binges/28 days

  2. Eating-Disorder Psychopathology [ Time Frame: Post-treatment (3 months) ]
    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).

  3. Depressive Symptoms [ Time Frame: Post-treatment (3 months) ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (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
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Contact: Valentina Ivezaj, Ph.D. 203-785-7210 valentina.ivezaj@yale.edu

Locations
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United States, Connecticut
Yale Department of Psychiatry Recruiting
New Haven, Connecticut, United States, 06510
Contact: Valentina Ivezaj, Ph.D.    203-785-7210    valentina.ivezaj@yale.edu   
Principal Investigator: Carlos M Grilo, Ph.D.         
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Carlos M Grilo, Ph.D. Yale University
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Binge-Eating Frequency [ Time Frame: Post-treatment (3 months) ]
    Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
  • Body Mass Index [ Time Frame: Post-treatment (3 months) ]
    BMI is calculated using measured height and weight (e.g., percent loss).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Binge-Eating Remission [ Time Frame: Post-treatment (3 months) ]
    Categorical: zero binges/28 days
  • Eating-Disorder Psychopathology [ Time Frame: Post-treatment (3 months) ]
    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 [ Time Frame: Post-treatment (3 months) ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
Official Title  ICMJE Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity
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.
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. This study examined the effectiveness of two leading but distinct treatments - lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) - alone and in combination, for BED in patients with obesity. LDX is the first and only FDA-approved medication for the treatment of BED and has demonstrated short-term effectiveness relative to placebo. CBT is the best-established psychological treatment, has demonstrated short-term effectiveness and "treatment specificity" (i.e., superiority to a variety of control and active treatments), has shown longer-term superiority to fluoxetine, and longer-term durability of outcomes. N=180 participants with BED and obesity will be randomly assigned to one of three interventions, CBT alone, LDX alone, or CBT combined with LDX. This RCT will provide new findings regarding the relative effectiveness of LDX, CBT, and combined CBT+LDX for patients with obesity and BED. No such study has been performed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge-Eating Disorder
  • Obesity
Intervention  ICMJE
  • Drug: Lisdexamfetamine Dimesylate
    Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
  • Behavioral: Cognitive-Behavioral Therapy
    Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
  • Other: Combination LDX and Cognitive-Behavioral Therapy
    Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
Study Arms  ICMJE
  • Active Comparator: LDX
    Intervention: Drug: Lisdexamfetamine Dimesylate
  • Active Comparator: Cognitive-Behavioral Therapy
    Intervention: Behavioral: Cognitive-Behavioral Therapy
  • Active Comparator: LDX and Cognitive Behavioral Therapy
    Intervention: Other: Combination LDX and Cognitive-Behavioral Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019) 		180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valentina Ivezaj, Ph.D. 203-785-7210 valentina.ivezaj@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924193
Other Study ID Numbers  ICMJE 2000022480_b
1R01DK114075-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Carlos M Grilo, Ph.D. Yale University
PRS Account Yale University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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