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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title: Methylphenidate Efficacy and Safety in ADHD Preschoolers

Status Completed

Clinical Trial 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).

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

• NCT number: NCT00018863
• Study type: Interventional
• Source: New York State Psychiatric Institute
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2001
• Completion date: November 30, 2006