An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

• Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)

Exclusion Criteria:

• Subjects who are known to not respond to methylphenidate

• Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components

• Have marked anxiety, tension or agitation

• Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder