An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness and safety of OROS*methylphenidate/CONCERTA* vs. immediate release methylphenidate as a treatment for ADHD specifically for those children who have behavioural difficulties in the afternoon/after-school and evening periods.

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

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired

• Eligible patients will be evaluated after a minimum 3 day washout period without ADHD medication

• In addition, patients must also have a CGI-Severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible

• Patients could have had no prior treatment for ADHD or are presently taking something or could have had ADHD medication treatment in the past

Exclusion Criteria:

• No patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of Tourette's disorder, or a family history of Tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing

• No patient with inability to swallow the medication whole, those with any unstable medical illness were excluded