Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Phase 4 Completed 357 enrolled Ortho-McNeil Janssen Scientific Affairs, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated with OROS MPH to those treated with placebo.

Timeline

Start: 2009-07
Primary completion: 2010-02
Completion: 2010-02

Outcome

Met primary endpoint

paper OROS methylphenidate-treated subjects exhibited a significantly greater mean (SD) AISRS score improvement than placebo subjects (-17.1 [12.44] vs -11.7 [13.30]; P < .001). PMID 27487193 ↗

Publications

Goodman DW, Starr HL, Ma YW, Rostain AL, Ascher S, Armstrong RB. Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission. J Clin Psychiatry. 2017 Jan;78(1):105-114. doi: 10.4088/JCP.15m10348.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	18 mg	Oral
Subject	Methylphenidate	Small molecule	36 mg	Oral
Subject	Methylphenidate	Small molecule	54 mg	Oral
Subject	Methylphenidate	Small molecule	72 mg	Oral