NCT00018863

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

Methylphenidate Efficacy and Safety in ADHD Preschoolers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (planned)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	Methylphenidate

Timeline

• Start date: 2001-04-01
• Primary completion: 2006-03-31
• Completion: 2006-11-30
• First posted: 2001-07-09
• Last updated: 2020-12-02

Locations

6 sites across 1 country: United States