OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Utah
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.