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OpenTrials
Completed

NCT Number: NCT00018863

Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)

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).

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, Irvine, Irvine, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Methylphenidate Efficacy and Safety in ADHD Preschoolers

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Jul 9, 2001
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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