Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Completed · Phase 2

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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 months with either extended release methylphenidate or behavioral therapy.

Key facts

Study ID

NCT00409708

Run by

Novartis

People needed

142

Starts

2006-11-01

Last updated by the study team

2011-05-17

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Pharmaceuticals Investigational site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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