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

Phase 4 Completed 464 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: 2012-04-17
Primary completion: 2014-01-22
Completion: 2014-01-22

Outcome

Missed primary endpoint

registry analysis (unspecified test); SPD489 vs OROS-MPH; p = 0.0717; Difference in LS Mean -2.1 (95% CI -4.3 to 0.2); mixed effects model for repeated measure NCT01552915 ↗

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	30 mg	Oral
Subject	Lisdexamfetamine Dimesylate	Small molecule	70 mg	Oral
Comparator	Methylphenidate	Small molecule	18 mg	Oral
Comparator	Methylphenidate	Small molecule	72 mg	Oral