NCT00937040

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

A Placebo Controlled Double-Blind, Parallel Group, Individualizing Dosing Study Optimizing Treatment of Adults With Attention Deficit Hyperactivity Disorder to an Effective Response With OROS Methylphenidate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The hypothesis is that Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCL (OROS MPH) is safe and effective in improving Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults with ADHD when compared to placebo as demonstrated using specific study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled study to evaluate the efficacy and safety of OROS MPH using the optimal dose for each adult patient in the study with ADHD. The primary efficacy variable in this study is the change from baseline to final evaluation using the Adult ADHD Investigator Symptom Rating Scale (AISRS) to measure patient ADHD symptoms. Participants will also be assessed for adverse events throughout the study. Patients will initiate treatment with oral OROS MPH 18 mg or matching placebo at baseline and continue morning dosing with increases every week until an optimal dose is achieved, up to the maximum of 72 mg/day of OROS MPH or matching placebo. Eligible patients will remain in the study for a maximum of 6 weeks.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	OROS MPH	Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks
DRUG	Placebo	Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks
DRUG	OROS MPH Tablets	Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks
DRUG	Placebo Tablets	Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-07-10
• Last updated: 2013-07-30
• Results posted: 2011-08-05