Summary

Eligibility
for people ages 3-5 (full criteria)
Location
at Irvine, California and other locations
Dates
study started

Description

Summary

This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).

Official Title

Methylphenidate Efficacy and Safety in ADHD Preschoolers

Details

Young children age 3-5.5 years will be studied. The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. Participants will be monitored by regular visits with a study physician. Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring

Keywords

Attention Deficit Disorder With Hyperactivity ADHD Hyperkinesis Methylphenidate

Eligibility

For people ages 3-5

Boys and girls who are:

  • Between the ages of 3-5.5 years
  • Qualified as having ADHD by our diagnostic evaluations and clinical staff
  • Otherwise generally healthy
  • Willing, and have parents that are willing, to attend all visits required by the study
  • Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week
  • In classrooms with teachers that are willing to participate by completing rating scale

Locations

  • University of California, Irvine
    Irvine California United States
  • University of California, Los Angeles
    Los Angeles California United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
New York State Psychiatric Institute
Links
Specific information on ADHD
ID
NCT00018863
Phase
Phase 3
Study Type
Interventional
Last Updated