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

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ClinicalTrials.gov Identifier: NCT00018863
Recruitment Status : Unknown
Verified October 2006 by New York State Psychiatric Institute.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2001
Last Update Posted : November 4, 2013
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Methylphenidate Efficacy and Safety in ADHD Preschoolers
Study Start Date : April 2001
Primary Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018863

United States, California
University of California, Irvine
Irvine, California, United States
University of California, Los Angeles
Los Angeles, California, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, New York
New York State Psychiatric Institute
New York, New York, United States
New York University School of Medicine
New York, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Study Chair: Laurence Greenhill, M.D.
More Information

Additional Information:
Conners CK: Controlled trial of methylphenidate in preschool children with minimal brain dysfunction. Int J Ment Health (4):61-74, 1975.

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00018863     History of Changes
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 )
First Posted: July 9, 2001    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: October 2006

Keywords provided by New York State Psychiatric Institute:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents