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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 months with either extended release methylphenidate or behavioral therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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