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

NCT03926052 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-12-17

Study results available
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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.

Conditions

Interventions

DRUG

Lisdexamfetamine Dimesylate

Participants randomly assigned to this arm will receive 12 weeks of LDX medication.

DRUG

Placebo

Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.

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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2024-11-18
Completion
2024-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03926052 on ClinicalTrials.gov