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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00018863

Collaborator

National Institute of Mental Health (NIMH) (NIH)

165

Enrollment

Locations

Actual Duration (Months)

27.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Methylphenidate	Phase 3

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Methylphenidate Efficacy and Safety in ADHD Preschoolers

Actual Study Start Date :

Apr 1, 2001

Actual Primary Completion Date :

Mar 31, 2006

Actual Study Completion Date :

Nov 30, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	University of California, Irvine	Irvine	California	United States
2	University of California, Los Angeles	Los Angeles	California	United States
3	Johns Hopkins University	Baltimore	Maryland	United States
4	New York State Psychiatric Institute	New York	New York	United States
5	New York University School of Medicine	New York	New York	United States
6	Duke University Medical Center	Durham	North Carolina	United States