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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Notify MeKey information
Conditions
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
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
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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