CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults
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 pilot study is to evaluate the safety, tolerability and potential
      effectiveness of CONCERTAÂ® (methylphenidate hydrochloride extended-release tablets), a
      central nervous system (CNS) stimulant for the treatment of adults with Attention Deficit
      Hyperactivity Disorder (ADHD).
    

Detailed description: 
      CONCERTA® is a long-acting form of methylphenidate (a CNS stimulant). Methylphenidate is a
      recognized first-line treatment for ADHD in children and adolescents. It is widely
      acknowledged in the scientific literature that the disorder often will persist in adulthood,
      and is associated with significant morbidity and undesirable outcomes. Despite this, few
      studies have been conducted to investigate the efficacy and safety of stimulant therapy in
      treating ADHD in adults. As a consequence, drug treatment options for adult sufferers of ADHD
      are limited. The primary objective of this pilot, open-label study is to evaluate the safety,
      tolerability and potential effectiveness of CONCERTA® (18, 36, 54 or 72 mg of methylphenidate
      hydrochloride, administered once-daily) in adult subjects with Attention Deficit
      Hyperactivity Disorder (ADHD). Patients cannot have been treated with any methylphenidate- or
      amphetamine-containing medication within 4 weeks of screening visit. Once deemed eligible,
      subjects will be started on 18 mg of CONCERTA® once-daily for 3 days, titrated up on Day 4 to
      36 mg and maintained at this dose for 7 days. Depending on patient response, the dose of
      CONCERTA® can continue to be titrated up every 7 days, first to 54 mg and then to a maximum
      of 72 mg per day, in order to achieve the optimal dose for each patient. The primary efficacy
      outcomes will be the changes from baseline to the end of treatment in the inattention and
      hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD
      Rating Scale (CARRS). Safety and tolerability will be monitored throughout the study. The
      study hypothesis is that stimulant therapy in treating adult ADHD will be safe and effective,
      measured by the Conners' Adult ADHD Rating Scale (CAARS) score. CONCERTA® is taken orally,
      once-daily. Starting with CONCERTA® 18 mg for 3 days, subjects are titrated up on Day 4 to 36
      mg for 7 days. Depending on response, tolerability and clinician's discretion, the dose of
      CONCERTA® can continue to be titrated up every 7 days, first to 54 mg and then to a maximum
      of 72 mg per day (two 36 mg tablets), until each subject's optimal dose is achieved. The
      titration period will last a maximum of 24 days.
    

Intervention name(s): CONCERTA (OROS methylphenidate hydrochloride)
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; once-day oral tablets