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

NCT03924193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2024-10-17

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Carlos M Grilo, Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2023-09-13
Completion
2023-09-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924193 on ClinicalTrials.gov