Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924193
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924193


Contacts
Layout table for location contacts
Contact: Valentina Ivezaj, Ph.D. 203-785-7210 valentina.ivezaj@yale.edu

Locations
Layout table for location information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03924193    
Other Study ID Numbers: 2000022480_b
1R01DK114075-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Mental Disorders
Hyperphagia
 Signs and Symptoms, Digestive
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents