Status:
COMPLETED
Lab School Day Study for CONCERTA of Older Children With ADHD
Lead Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
9-12 years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention defic...
Detailed Description
The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD, when compared to placebo as demonstrated using specifi...
Eligibility Criteria
Inclusion
- ADHD diagnosis of all subtypes (except Not Otherwise Specified)
- Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) scores \> =90th percentile relative to the general population of children by age and gender
- Patients currently receiving ADHD medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit
- Ability to read and understand English
- Ability to attend school regularly.
Exclusion
- Estimated Full Scale IQ score of 80 or below
- Severe Learning Disability
- History of, or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, sleep disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of Tourette's syndrome
- Weight \< 3rd percentile for age
- History of hospitalization for treatment of a mood, anxiety, or psychotic disorder
- History of failed response to methylphenidate.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00799409
Start Date
December 1 2008
End Date
June 1 2009
Last Update
May 9 2014
Active Locations (2)
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1
Irvine, California, United States
2
Houston, Texas, United States