drugset / Trial / NCT03260205
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.
Timeline
- Start
- 2017-09-06
- Primary completion
- 2018-10-23
- Completion
- 2018-10-23
Outcome
Met primary endpoint
registry p = 0.0242; Difference in Least Square Mean -5.9 (95% CI -11.01 to -0.78) NCT03260205 ↗
Publications
- Farhat LC, Sugaya LS, Bloch MH, Childress A, Cortese S, Fatori D, Salum GA, Rohde LA, Polanczyk GV. Individual Participant Data Meta-Analysis: Moderators of Response to Stimulants for Preschool Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2026 Jun;65(6):781-792. doi: 10.1016/j.jaac.2025.09.012. Epub 2025 Sep 18.
- Childress AC, Lloyd E, Jacobsen L, Gunawardhana L, Johnson SA Jr, Findling RL. Efficacy and Safety of Lisdexamfetamine in Preschool Children With Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2022 Dec;61(12):1423-1434. doi: 10.1016/j.jaac.2022.03.034. Epub 2022 May 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 5 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 10 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 20 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 30 mg | Oral |