drugset / Trial / NCT03924193
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
Phase 3
Completed
141 enrolled
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2019-03-25
- Primary completion
- 2023-09-13
- Completion
- 2023-09-13
Publications
- Yurkow S, Bowman WP, Ivezaj V, Grilo CM. Examining Heterogeneity of Patient Outcomes in a Randomized Controlled Trial for Binge-Eating Disorder Testing Cognitive-Behavioral Therapy and Lisdexamfetamine, Alone and Combined. Int J Eat Disord. 2026 Apr 29:10.1002/eat.70115. doi: 10.1002/eat.70115. Online ahead of print.
- Yurkow S, Ivezaj V, Pittman B, Grilo CM. Preferences for Lisdexamfetamine vs Cognitive-Behavioral Therapy for Binge-Eating Disorder: Correlates and Outcomes. J Clin Psychiatry. 2025 May 7;86(2):24m15552. doi: 10.4088/JCP.24m15552.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lisdexamfetamine | Other / unclassified | — | — |