Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Extended Release Methylphenidate (Drug); Behavior Therapy (Behavioral)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Affiliation: Novartis
Summary
This study will assess the frequency of chromosomal abnormalities measured in circulating
lymphocytes in treatment-naive children with ADHD treated for 3 months with either extended
release methylphenidate of behavioral therapy.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Frequency of chromosomal abnormalities measured in circulating lymphocytes
Secondary outcome: Frequency of persistent chromosomal changes (stable translocations)Pharmacokinetic/Pharmacodynamic relationship of methylphenidate blood levels and cytogenetic changes Efficacy evaluation measured through Connors ADHD/DSM-IV Scale for parents, global Improvement rating of the Clinical Global Impression scale, and severity of illness rating of the Clinical Global Impression scale.
Detailed description:
This study will determine whether the administration of extended-release methylphenidate in
treatment-naïve children with ADHD affects the frequency of chromosomal abnormalities.
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
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
Locations and Contacts
Novartis Pharmaceuticals Investigational site, Houston, Texas 77007, United States
Additional Information
Starting date: November 2006
Ending date: March 2008
Last updated: December 20, 2007
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