Clinical trial NCT00409708: Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: An Open-label, Behavioral-treatment-controlled Evaluation of the Effects of Extended Release Methylphenidate on the Frequency of Cytogenetic Abnormalities in Children 6 - 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder,
ADHD
Cytogenetic abnormalities,
extended-release methylphenidate,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-11
Enrollment: 142
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 months with either extended release methylphenidate or behavioral therapy.

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 chromosomal abnormalities.

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

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
measure: Number of Sister Chromatoid Exchanges Per Cell
timeFrame: baseline and at end of treatment (Week 12)
measure: Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes
timeFrame: End of treatment (Week 12)
measure: Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)
timeFrame: Baseline to end of treatment (Week 12)
measure: Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)
timeFrame: From baseline to the end of treatment (Week 12)
measure: Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)
timeFrame: From baseline to the end of treatment (Week 12)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novartis Pharmaceuticals Investigational site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: