Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study
| Autor: | Ann C. Childress, Justine Kent, Kenneth S. Koblan, Sharon B. Wigal, Robert Goldman, Antony Loebel, Seth C. Hopkins, Joyce Tsai, Jay Hsu |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Evening Placebo law.invention dasotraline children Double-Blind Method Randomized controlled trial law Internal medicine Developmental and Educational Psychology medicine Insomnia ADHD Humans Child Adverse effect Dose-Response Relationship Drug Symptom severity Decreased appetite Clinical Psychology 1-Naphthylamine Treatment Outcome Current Perspectives Attention Deficit Disorder with Hyperactivity Delayed-Action Preparations randomized controlled trial Central Nervous System Stimulants medicine.symptom Dasotraline Psychology |
| Zdroj: | Journal of Attention Disorders |
| ISSN: | 1557-1246 1087-0547 |
| DOI: | 10.1177/1087054719864644 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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