A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

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 description: 
      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. Eligible patients may continue prolonged-release methylphenidate in
      an open-label extension study for an additional 7 weeks.
    

Intervention name(s): methylphenidate hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Attention deficit/hyperactivity disorder; methylphenidate; central nervous system stimulants