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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

• NCT number: NCT00937040
• Study type: Interventional
• Source: Ortho-McNeil Janssen Scientific Affairs, LLC
• Status: Completed
• Phase: Phase 4
• Start date: July 2009
• Completion date: February 2010