A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder

Phase 4 Completed 297 enrolled Massachusetts General Hospital McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · collab

RandomizedCrossoverDouble-blindTreatment

Summary

This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.

Timeline

Start: 2003-06
Primary completion: 2007-08
Completion: 2007-08

Publications

Biederman J, Mick E, Fried R, Wilner N, Spencer TJ, Faraone SV. Are stimulants effective in the treatment of executive function deficits? Results from a randomized double blind study of OROS-methylphenidate in adults with ADHD. Eur Neuropsychopharmacol. 2011 Jul;21(7):508-15. doi: 10.1016/j.euroneuro.2010.11.005. Epub 2011 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Methylphenidate	Small molecule	1.3 mg/kg	—
Comparator	Methylphenidate	Small molecule	144 mg	—

A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder

Summary

Timeline

Publications

Drugs

Indications