drugset / Trial / NCT00877487
Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.
Timeline
- Start
- 2009-04-30
- Primary completion
- 2010-07-08
- Completion
- 2010-07-08
Publications
- Results Brams M, Weisler R, Findling RL, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design. J Clin Psychiatry. 2012 Jul;73(7):977-83. doi: 10.4088/JCP.11m07430. Epub 2012 Jun 12.
- Weisler RH, Babcock T, Adeyi B, Brams M. Relationship of ADHD symptoms and global illness severity in adults treated with lisdexamfetamine dimesylate. Postgrad Med. 2014 Sep;126(5):31-41. doi: 10.3810/pgm.2014.09.2798.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 30 mg | — |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 50 mg | — |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 70 mg | — |