CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03926052
NCT03926052Phase 3Completed
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Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity

Yale University·interventional·Posted Apr 24, 2019·Updated Dec 17, 2025

In Brief

A Phase 3 clinical trial evaluating Lisdexamfetamine Dimesylate and Placebo for Binge-Eating Disorder and Obesity. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge-Eating Disorder, Obesity
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 24, 2019
Enrollment StartAug 7, 2019
Primary CompletionNov 18, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.2 years ago

Interventions

Lisdexamfetamine Dimesylatedrug

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

Placebodrug

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