Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study.

Journal of Attention Disorders
S WigalRobert Goldman

Abstract

Objective: To evaluate the efficacy and safety of dasotraline for treatment of ADHD in children. Method: Children (ages 6-12 years; N = 112) with ADHD were randomized, double-blind, to 14 days of once-daily evening doses of dasotraline 4 mg or placebo. ADHD symptom severity was measured at baseline and Day 15 in seven, 30-min classroom sessions using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and the Permanent Product Measure of Performance (PERMP) math test. Results: Significant improvement was observed for dasotraline versus placebo in the SKAMP-combined score (-3.2 vs. +2.0; p < .001; effect size = 0.85) and SKAMP and PERMP subscale scores. The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%). Conclusion: In this laboratory classroom study, dasotraline 4 mg was found to be an efficacious and generally well-tolerated treatment for ADHD in children aged 6 to 12 years.

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Citations

Sep 18, 2020·Expert Opinion on Emerging Drugs·Marco PozziMaria Nobile
Nov 5, 2020·Expert Opinion on Emerging Drugs·Ann C ChildressMargaret D Weiss
Mar 17, 2021·International Clinical Psychopharmacology·Lenard A AdlerAntony Loebel
Jul 29, 2021·Journal of Psychopharmacology·David J Heal, Sharon L Smith

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