Phase 2
N=109
Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00409708 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12) — 1.05; 0.75; 0.53; 0.41 number of abnormalities
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy (Drug); Behavior Therapy (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12) |
1.05; 0.75; 0.53; 0.41 | — |
| PRIMARY The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12) |
5.76; 5.71; 3.63; 4.19 | — |
| SECONDARY Number of Sister Chromatoid Exchanges Per Cell |
7.807; 7.533; 7.213; 7.303 | — |
| SECONDARY Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes |
— | — |
| SECONDARY Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) |
-17.0; -7.0 | — |
| SECONDARY Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I) |
1.9; 3.0 | — |
| SECONDARY Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S) |
-1.9; -0.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00409708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.