Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type

• Parent and Teacher Ratings >85 percentile on inattention and/or hyperactivity/impulsivity scales

• Estimated Intelligence Quotient (IQ) > 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test

Exclusion Criteria:

• Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization, psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing of the gastrointestinal tract, or epilepsy

• Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation

• Use within 14-days of a monoamine oxidase inhibitor

• History of side effects on any methylphenidate preparation that required stopping the medication

• Inability to swallow a capsule or tablet

• Chronic treatment with coumarin, clonidine, or tricyclic antidepressants