drugset / Trial / NCT00500071
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
NaSingle-groupOpen-labelTreatment
Summary
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
Timeline
- Start
- 2007-06-28
- Primary completion
- 2008-01-02
- Completion
- 2008-01-02
Publications
- Results Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):649-62. doi: 10.1089/cap.2008.0165.
- Results Katic A, Ginsberg L, Jain R, Adeyi B, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Turgay A, Findling RL. Clinically relevant changes in emotional expression in children with ADHD treated with lisdexamfetamine dimesylate. J Atten Disord. 2012 Jul;16(5):384-97. doi: 10.1177/1087054710389990. Epub 2010 Dec 20.
- Results Turgay A, Ginsberg L, Sarkis E, Jain R, Adeyi B, Gao J, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Findling RL. Executive function deficits in children with attention-deficit/hyperactivity disorder and improvement with lisdexamfetamine dimesylate in an open-label study. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):503-11. doi: 10.1089/cap.2009.0110.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lisdexamfetamine | Other / unclassified | 20 mg | — |
| Subject | Lisdexamfetamine | Other / unclassified | 30 mg | — |
| Subject | Lisdexamfetamine | Other / unclassified | 40 mg | — |
| Subject | Lisdexamfetamine | Other / unclassified | 50 mg | — |
| Subject | Lisdexamfetamine | Other / unclassified | 60 mg | — |
| Subject | Lisdexamfetamine | Other / unclassified | 70 mg | — |