Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00409708

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Extended Release Methylphenidate Behavioral: Behavior Therapy	Phase I Phase II

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Novartis:

Primary Outcome Measures:

Frequency of chromosomal abnormalities measured in circulating lymphocytes [ Time Frame: Baseline, 3 month, end of washout period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency of persistent chromosomal changes (stable translocations.) If no cytogenetic effect is observed, these samples will not be evaluated [ Time Frame: Baseline, 3 month, end of washout period ] [ Designated as safety issue: Yes ]
Pharmacokinetic/Pharmacodynamic relationship of methylphenidate blood levels and cytogenetic changes. If no cytogenetic effect is observed, these samples will not be evaluated [ Time Frame: Day 28, Day 84, and Day 126 ] [ Designated as safety issue: No ]
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. [ Time Frame: Baseline, Day 28, Day 56, Day 84 ] [ Designated as safety issue: No ]

Enrollment:	141
Study Start Date:	November 2006
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Extended Release Methylphenidate
2	Behavioral: Behavior Therapy

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

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409708

Locations

United States, Texas
Novartis Pharmaceuticals Investigational site
Houston, Texas, United States, 77007

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRIT124D2201
Study First Received:	December 8, 2006
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00409708 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Attention Deficit Hyperactivity Disorder,
ADHD
Cytogenetic abnormalities,
extended-release methylphenidate,

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms
Dopamine

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Chromosome Aberrations
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Congenital Abnormalities

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Methylphenidate
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions

Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Chromosome Aberrations
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Congenital Abnormalities
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009