Status:
COMPLETED
Neuroimaging of the Effects of Concerta in the Treatment of ADHD
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
9-25 years
Phase:
PHASE4
Brief Summary
A number of brain regions have been down to be altered in both structure and function in patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum. Patients with ADHD...
Detailed Description
Three age groups of subjects will be studied: school age children (aged 9-12), older adolescents (age 15-17 years) and young adults (age 20-25 years). Twenty subjects will be studied in each group. Al...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for Attention Deficit Hyperactivity Disorder
- Current clinical responder to Concerta (OROS-methylphenidate)
Exclusion
- IQ \< 95
- Presence of Learning Disorder
- Presence of an Affective or Psychotic Disorder
- Presence of a Substance/Alcohol Abuse/Dependence Disorder
- Presence of an Autism Spectrum Disorder
- Presence of a Tic Disorder
- Taking any psychotropic medication other than Concerta
- A medical condition requiring daily medication
- Previous adverse or non response to Concerta
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00778310
Start Date
November 1 2008
End Date
December 1 2010
Last Update
July 13 2012
Active Locations (1)
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1
Dept of Psychiatry, UTHSCSA
San Antonio, Texas, United States, 78229