Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Phase 4 Completed 549 enrolled Shire

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Timeline

Start: 2012-04-03
Primary completion: 2014-05-22
Completion: 2014-05-22

Outcome

Met primary endpoint

registry analysis (unspecified test); Lisdexamfetamine Dimesylate vs Methylphenidate; p = 0.0013; Difference in LSM -3.4 (95% CI -5.4 to -1.3); Mixed Models Analysis NCT01552902 ↗

registry analysis (unspecified test); Placebo vs Lisdexamfetamine Dimesylate; p < 0.0001; Difference in LSM -8.5 (95% CI -11 to -6); Mixed Models Analysis NCT01552902 ↗

Publications

Newcorn JH, Nagy P, Childress AC, Frick G, Yan B, Pliszka S. Randomized, Double-Blind, Placebo-Controlled Acute Comparator Trials of Lisdexamfetamine and Extended-Release Methylphenidate in Adolescents With Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2017 Nov;31(11):999-1014. doi: 10.1007/s40263-017-0468-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lisdexamfetamine Dimesylate	Small molecule	70 mg	Oral
Comparator	Methylphenidate	Small molecule	72 mg	Oral