Clinical Trials Logo

Clinical Trial Summary

ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.


Clinical Trial Description

Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06413433
Study type Interventional
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 212-332-5061
Email sol-bed-301@axsome.com
Status Recruiting
Phase Phase 3
Start date April 26, 2024
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT04572087 - Ameliorating Cognitive Control in Binge Eating Disorder N/A
Completed NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Completed NCT03678766 - CHARGE: Controlling Hunger and ReGulating Eating N/A
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Terminated NCT03279731 - Binge Eating Liraglutide Intervention Phase 3
Terminated NCT04278755 - Binge Eating & Birth Control Phase 2
Completed NCT02419326 - Uniting Couples In the Treatment of Eating Disorders (UNITE) N/A
Completed NCT00210808 - A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity Phase 2/Phase 3
Recruiting NCT05937243 - Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating N/A
Completed NCT04115852 - Interoceptive Nutritional Processing in Healthy Participants and Patients With Binge-Eating-Disorder
Completed NCT03113669 - Project BITE: Binge Intervention Target Effectiveness N/A
Completed NCT04265131 - Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome? N/A
Recruiting NCT06431854 - Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program N/A
Completed NCT06230107 - The Effects of Nutritional Intervention in Participants With Eating Disorders. N/A
Completed NCT03712748 - Online Imaginal Exposure N/A
Recruiting NCT04076553 - Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training N/A
Not yet recruiting NCT04101032 - eBEfree - an ICT Adaptation of BEfree N/A
Terminated NCT05911334 - Feasibility of the ROADE Program N/A
Completed NCT03317379 - Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy N/A
Completed NCT02783872 - Emotion Regulation and Binge Eating in Youth With Obesity