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

November 30, 2020 updated by: Laurence Greenhill, New York State Psychiatric Institute

Methylphenidate Efficacy and Safety in ADHD Preschoolers

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

165

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States
        • University of California, Irvine
      • Los Angeles, California, United States
        • University of California, Los Angeles
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins University
    • New York
      • New York, New York, United States
        • New York State Psychiatric Institute
      • New York, New York, United States
        • New York University School of Medicine
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Laurence Greenhill, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2001

Primary Completion (Actual)

March 31, 2006

Study Completion (Actual)

November 30, 2006

Study Registration Dates

First Submitted

July 5, 2001

First Submitted That Met QC Criteria

July 6, 2001

First Posted (Estimate)

July 9, 2001

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #3761
  • U01MH060903 (U.S. NIH Grant/Contract)
  • U01MH060642 (U.S. NIH Grant/Contract)
  • U01MH060943 (U.S. NIH Grant/Contract)
  • U01MH060848 (U.S. NIH Grant/Contract)
  • U01MH060900 (U.S. NIH Grant/Contract)
  • U01MH060833 (U.S. NIH Grant/Contract)
  • DSIR CT-M2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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