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

Novartis

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy; Behavioral: Behavior Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409708

CRIT124D2201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy

2

Other group

Treatment:

Behavioral: Behavior Therapy