Dasotraline Binge Eating Disorder Study

Summary

Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with moderate to severe Binge Eating Disorder (BED)

Timeline

Start

2015-10

Primary completion

2016-10

Completion

2016-10

Outcome

Met primary endpoint

paper significantly greater reduction in binge-eating days per week at study endpoint (vs placebo; least squares mean [SE] difference score, -0.99 [0.17]; P < .0001 PMID 32926604 ↗

Publications

• Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.
• McElroy SL, Hudson JI, Grilo CM, Guerdjikova AI, Deng L, Koblan KS, Goldman R, Navia B, Hopkins S, Loebel A. Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A Randomized, Placebo-Controlled, Flexible-Dose Clinical Trial. J Clin Psychiatry. 2020 Sep 8;81(5):19m13068. doi: 10.4088/JCP.19m13068.

Drugs

Indications