CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 141 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate +2 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/NCT03924193
NCT03924193Phase 3Completed
CompareCT.gov

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

Yale University·interventional·Posted Apr 23, 2019·Updated Oct 17, 2024

In Brief

A Phase 3 clinical trial evaluating Lisdexamfetamine Dimesylate, Cognitive-Behavioral Therapy, and 1 other intervention for Binge-Eating Disorder and Obesity. Completed, enrolled 141 participants across 1 site.

Detailed 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.

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 23, 2019
Enrollment StartMar 25, 2019
Primary CompletionSep 13, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.2 years ago

Interventions

Lisdexamfetamine Dimesylatedrug

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

Cognitive-Behavioral Therapybehavioral

Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy

Combination LDX and Cognitive-Behavioral Therapyother

Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy