CompletedPhase 2

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

United States142 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range6 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)

Timeframe: baseline and at end of treatment (Week 12)

The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)

Timeframe: baseline and at end of treatment (Week 12)

Trial details

NCT IDNCT00409708

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-03

Results submitted2010-12-06

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials