Treatment of College Students With Attention-Deficit/Hyperactivity Disorder (ADHD) Using OROS Methylphenidate

• Status: Withdrawn
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the proposed study is to determine the effectiveness of methylphenidate HCl (Concerta) in college students with ADHD. This study will consist of 110 college students between the ages of 18 and 25 who are enrolled full-time in a local or junior college. The study consists of an 8-week double-blind, placebo-controlled trial of placebo versus methylphenidate HCl (Concerta®) followed by a 10-week extension of open label methylphenidate HCl (Concerta®).

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

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Ages 18-25 years, inclusive

• DSM-IV diagnosis of ADHD (any subtype)

• Clinical Global Impressions scale (CGI)-Severity score of ≥4 ("Moderately ill" or higher) for ADHD

Exclusion Criteria:

• Pregnancy or a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk

• Abnormal liver function

• History of pervasive developmental disorder, schizophrenia, other psychotic disorders, or eating disorders

• Currently taking other psychotropic medications from which discontinuation would present a significant risk (we will not allow subjects with a satisfactory medication response to discontinue that medication and to participate)

• Active substance dependence or lack of control of substance use that does not allow for safe medication administration