Status:
COMPLETED
Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Novartis
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
This study will assess the frequency of chromosomal abnormalities measured in circulating lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD) treated for 3 mon...
Detailed Description
This study will determine whether the administration of extended-release methylphenidate in treatment-naïve children with Attention Deficit Hyperactivity Disorder (ADHD) affects the frequency of chrom...
Eligibility Criteria
Inclusion
- Children of both genders, 6-12 years old
- Written informed consent by the parent and the patient (over 7)
- Diagnosis of ADHD
- Age-appropriate cognitive functioning
- All patients who had at least one post-baseline cytogenetic assessment in the core study can enter the observation phase.
Exclusion
- History of malignant neoplasm
- History of seizures (except childhood febrile seizures)
- Hyperthyroidism
- Concurrent medical condition which may interfere with study
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00409708
Start Date
November 1 2006
Last Update
May 17 2011
Active Locations (1)
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1
Novartis Pharmaceuticals Investigational site
Houston, Texas, United States, 77007