Methylphenidate Efficacy and Safety in ADHD Preschoolers

New York State Psychiatric Institute6 sites in 1 country165 target enrollmentApril 1, 2001

ConditionsAttention Deficit Disorder With Hyperactivity

DrugsMethylphenidate

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: New York State Psychiatric Institute
Enrollment: 165
Locations: 6
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

April 1, 2001

End Date

November 30, 2006

Last Updated

5 years ago

Study Type

Interventional

Sex

All