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

Purpose

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	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Methylphenidate	Phase III

MedlinePlus related topics:

Attention Deficit Hyperactivity Disorder

Drug Information available for:

Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Safety/Efficacy Study

Official Title:	Methylphenidate Efficacy and Safety in ADHD Preschoolers

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	165
Study Start Date:	April 2001
Estimated Study Completion Date:	August 2004

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

Eligibility

Ages Eligible for Study:	3 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018863

Locations


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

National Institute of Mental Health (NIMH)

Investigators


Study Chair:	Laurence Greenhill, M.D.

More Information

Specific information on ADHD This link exits the ClinicalTrials.gov site

Publications of Results:

Kollins S, Greenhill L, Swanson J, Wigal S, Abikoff H, McCracken J, Riddle M, McGough J, Vitiello B, Wigal T, Skrobala A, Posner K, Ghuman J, Davies M, Cunningham C, Bauzo A. Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS). J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1275-83.

Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, Chuang S, Vitiello B, Skrobala A, Posner K, Abikoff H, Oatis M, McCracken J, McGough J, Riddle M, Ghuman J, Cunningham C, Wigal S. Stimulant-Related Reductions of Growth Rates in the PATS. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1304-1313.

Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, McGough J, Wigal S, Wigal T, Vitiello B, Skrobala A, Posner K, Ghuman J, Cunningham C, Davies M, Chuang S, Cooper T. Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1284-1293.

McGough J, McCracken J, Swanson J, Riddle M, Kollins S, Greenhill L, Abikoff H, Davies M, Chuang S, Wigal T, Wigal S, Posner K, Skrobala A, Kastelic E, Ghuman J, Cunningham C, Shigawa S, Moyzis R, Vitiello B. Pharmacogenetics of Methylphenidate Response in Preschoolers With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1314-1322.

Wigal T, Greenhill L, Chuang S, McGough J, Vitiello B, Skrobala A, Swanson J, Wigal S, Abikoff H, Kollins S, McCracken J, Riddle M, Posner K, Ghuman J, Davies M, Thorp B, Stehli A. Safety and Tolerability of Methylphenidate in Preschool Children With ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-1303.

Other Publications:

Schleifer M, Weiss G, Cohen N, Elman M, Cvejic H, Kruger E. Hyperactivity in preschoolers and the effect of methylphenidate. Am J Orthopsychiatry. 1975 Jan;45(1):38-50.

Handen BL, Feldman HM, Lurier A, Murray PJ. Efficacy of methylphenidate among preschool children with developmental disabilities and ADHD. J Am Acad Child Adolesc Psychiatry. 1999 Jul;38(7):805-12.

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

Barkley RA. The effects of methylphenidate on the interactions of preschool ADHD children with their mothers. J Am Acad Child Adolesc Psychiatry. 1988 May;27(3):336-41. No abstract available.

Mayes SD, Crites DL, Bixler EO, Humphrey FJ 2nd, Mattison RE. Methylphenidate and ADHD: influence of age, IQ and neurodevelopmental status. Dev Med Child Neurol. 1994 Dec;36(12):1099-107.

Musten LM, Firestone P, Pisterman S, Bennett S, Mercer J. Effects of methylphenidate on preschool children with ADHD: cognitive and behavioral functions. J Am Acad Child Adolesc Psychiatry. 1997 Oct;36(10):1407-15.

Study ID Numbers:	U01 MH60903, U01 MH60642, U01 MH60943, U01 MH60848, U01 MH60900, U01 MH60833, DSIR CT-M2
First Received:	July 5, 2001
Last Updated:	November 2, 2006
ClinicalTrials.gov Identifier:	NCT00018863
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):

ADHD

Study placed in the following topic categories:

Signs and Symptoms

Dopamine

Attention Deficit Disorder with Hyperactivity

Mental Disorders

Mental Disorders Diagnosed in Childhood

Methylphenidate

Neurologic Manifestations

Attention Deficit and Disruptive Behavior Disorders

Hyperkinesis

Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Disease

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Central Nervous System Stimulants

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00018863