Clinical Trial

Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)

Completed Phase 2/3
View on ClinicalTrials.gov →
Summary
This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.
Protocol Amendment History 5 changes
critical Trial completed 2026-08-07
critical Primary endpoint(s) modified 2026-08-07
notable Enrollment reduced: 60 -> 16 participants 2026-08-07
notable Primary completion moved earlier: 2027-05 -> 2026-06-04 2026-08-07
minor Completion moved earlier: 2027-05 -> 2026-06-04 2026-08-07
Trial Details
NCT Number NCT04599504
Lead Sponsor Yale University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Loss-of-control Eating, Obesity/Overweight
Enrollment 16 participants
Start Date 2022-01-02
Primary Completion 2026-06-04 (estimated)
Study Completion 2026-06-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-06