Clinical Trial: A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and

Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of three doses of prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult patients with attention deficit/hyperactivity disorder (ADHD).

Detailed Summary: Stimulant therapy is the mainstay of pharmacologic treatment for attention deficit/hyperactivity disorder (ADHD) in children and adolescents. Methylphenidate is the most commonly prescribed and most frequently studied stimulant medication for children and adolescents with this disorder. It is widely acknowledged in the scientific literature that ADHD often will persist into adulthood. Few large-scale, rigorous studies have been conducted to investigate the effectiveness and safety of stimulant therapy in treating ADHD in adults. This is a multicentre, double-blind, randomised, placebo-controlled, parallel group, dose-response study comparing three doses of prolonged-release methylphenidate (18, 36, and 72 mg once-daily) versus placebo in adult patients with ADHD. The primary efficacy outcome will be the change from baseline to the end of the double-blind phase in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale (CAARS). Additional measures of effectiveness will include the following scales: CAARS-self report, to rate items pertaining to the patient's behavior/problems; Clinical Global Impression (CGI), to rate the severity of a patient's illness; Sheehan's Disability Scale (SDS), to measure the extent to which a patient's work, social life or leisure activities and home life or family responsibilities are impaired by his/her symptoms; Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q); and the Global Assessment of Effectiveness. Safety and tolerability will be monitored throughout the study. The study hypothesis is that prolonged-release methylphenidate taken once-daily will produce clinically significant improvements compared with placebo on measures of inattention and hyperactivity/impulsivity of the Conners' Adult ADHD Rating Scale in patients with adult ADHD. Prolonged-release methylphenidate 18, 36 or 72 mg oral capsules, or placebo, taken once-daily for 5 weeks.
Sponsor: Janssen Pharmaceutica N.V., Belgium

Current Primary Outcome: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes from baseline to the end of treatment in: Conners' Adult ADHD Rating Scale; Clinical Global Impression; Sheehan's Disability Scale; Quality of Life Enjoyment and Satisfaction Questionnaire; and Global Assessment of Effectiveness

Original Secondary Outcome: Same as current

Information By: Janssen Pharmaceutica N.V., Belgium

Dates:
Date Received: October 28, 2005
Date Started: March 2005
Date Completion:
Last Updated: May 16, 2011
Last Verified: April 2010