NCT03926052

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide findings from a controlled test, amongst responders to acute treatments, whether LDX medication results in superior maintenance and longer-term outcomes than placebo. This is one of the few RCTs for BED of medication with follow-up after medication discontinuation.

Conditions

• Binge-Eating Disorder
• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-07
• Primary completion: 2024-11-18
• Completion: 2024-11-18
• First posted: 2019-04-24
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study