OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will look at the effectiveness of osmotic release oral system (OROS)
      methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in
      adults. Concerta has received FDA approval for childhood ADHD and there is documentation that
      it is effective in adult ADHD. However this trial will explore its effectiveness in treating
      symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III) criteria. Subjects
      will experience one screening visit and one baseline visit. Those who meet admission criteria
      will enter the double-blind phase. This will involve two 4-week treatment periods one of
      which will involve the use of Concerta and the other a placebo pill. Subjects who complete
      the double-blind phase will be allowed to enter a 180-day, open-label Concerta phase designed
      to assess long-term effects.
    

Detailed description: 
      ADHD affects from 3 to 5% of children, persists into adolescence 40 to 70% of these children
      and continues into adulthood in at least 50% of affected adolescents. Pharmacotherapy for
      ADHD in adults has paralleled that used for children, with generally positive results
      (Spencer, 1998). Never-the-less, it is not clear that the dimensions of medication response
      in adults are the same as in children. The extent to which the symptoms change with age
      remains open to question. This trial is created to include a variety of outcome measures
      which will enhance the number of symptoms assessed.

      Methylphenidate was the first medication shown to be effective in treatment for adults with
      ADHD and continues to be widely used. Several studies have demonstrated the usefulness of
      methylphenidate in adult ADHD (Wender et al, 1985, Spencer et al, 1995). These studies have
      not shown any unexpected drawbacks to treatment with methylphenidate. The extended release
      formulations represent an improvement over the immediate release versions for many patients.

      This is a double-blind, placebo-controlled, randomized, crossover trial comparing OROS
      methylphenidate with placebo. The double-blind trial will be preceded by an enrollment period
      consisting of a screening visit followed by a baseline visit. Patients who continue to meet
      admission criteria at baseline will be randomized into the first of two 4-week treatment
      periods. We will attempt to reach the highest tolerated dose size within 2 weeks and then
      observe the response over the last two weeks of each crossover phase. The double-blind period
      will be followed by a 180 day open-treatment, flexible-dose phase designed to assess
      long-term effects.
    

Intervention name(s): OROS methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo medication appears identical to the active medication OROS methylphenidate
Other intervention name(s): concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; adult; WRAADDS; OROS MPH; emotional dysregulation