Dasotraline Adult ADHD Study

Summary

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD.

Timeline

Start

2014-12

Primary completion

2016-09

Completion

2016-09

Outcome

Missed primary endpoint

paper Least squares mean reduction at week 8 in the ADHD RS-IV HV total score was not significantly greater (vs. placebo) PMID 33724251 ↗

paper or in the dasotraline 6 mg/day group (-16.5 vs. -13.9; P = 0.074; Hochberg correction). PMID 33724251 ↗

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.
• Adler LA, Goldman R, Hopkins SC, Koblan KS, Kent J, Hsu J, Loebel A. Dasotraline in adults with attention deficit hyperactivity disorder: a placebo-controlled, fixed-dose trial. Int Clin Psychopharmacol. 2021 May 1;36(3):117-125. doi: 10.1097/YIC.0000000000000333.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dasotraline	Small molecule	4 mg	—
Subject	Dasotraline	Small molecule	6 mg	—

Indications