drugset / Trial / NCT00557011
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
Timeline
- Start
- 2004-09
- Primary completion
- —
- Completion
- 2004-12
Publications
- Results Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007 Nov 1;62(9):970-6. doi: 10.1016/j.biopsych.2007.04.015. Epub 2007 Jul 12.
- Faraone SV, Spencer TJ, Kollins SH, Glatt SJ. Effects of lisdexamfetamine dimesylate treatment for ADHD on growth. J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):24-32. doi: 10.1097/00004583-201001000-00006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 30 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 50 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 70 mg | Oral |
| Comparator | Methylphenidate | Small molecule | 10 mg | — |
| Comparator | Methylphenidate | Small molecule | 20 mg | — |
| Comparator | Methylphenidate | Small molecule | 30 mg | — |