Status:
WITHDRAWN
Treatment of College Students With Attention-Deficit/Hyperactivity Disorder (ADHD) Using OROS Methylphenidate
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Attention-Deficit/Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
18-25 years
Phase:
PHASE4
Brief 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...
Detailed Description
There are very few trials on drug efficacy and safety treatment performed specifically for college students with Attention-Deficit/Hyperactivity Disorder (ADHD). Although data based on the adult popul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00931398
Start Date
April 1 2010
End Date
April 1 2010
Last Update
August 24 2012
Active Locations (1)
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1
Youth and Family Research Program
Pittsburgh, Pennsylvania, United States, 15213