Dasotraline Pediatric ADHD Study

Summary

This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.

Timeline

Start

2015-04

Primary completion

2016-07

Completion

2016-07

Outcome

Met primary endpoint

paper significant improvement at study endpoint in the ADHD RS-IV HV total score for the 4 mg/day dose versus placebo (-17.5 vs. -11.4; p < 0.001) PMID 30694697 ↗

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.
• Findling RL, Adler LA, Spencer TJ, Goldman R, Hopkins SC, Koblan KS, Kent J, Hsu J, Loebel A. Dasotraline in Children with Attention-Deficit/Hyperactivity Disorder: A Six-Week, Placebo-Controlled, Fixed-Dose Trial. J Child Adolesc Psychopharmacol. 2019 Mar;29(2):80-89. doi: 10.1089/cap.2018.0083. Epub 2019 Jan 29.

Drugs

Indications