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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03924193
• Other study ID #: 2000022480_b
• Secondary ID: 1R01DK114075-01A
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 25, 2019
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Yale Department of Psychiatry	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge-Eating Frequency	Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).	Post-treatment (3 months)
Primary	Body Mass Index	BMI is calculated using measured height and weight (e.g., percent loss).	Post-treatment (3 months)
Secondary	Binge-Eating Remission	Categorical: zero binges/28 days	Post-treatment (3 months)
Secondary	Eating-Disorder Psychopathology	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).	Post-treatment (3 months)
Secondary	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).	Post-treatment (3 months)