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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2006 by New York State Psychiatric Institute.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT00018863

First received: July 5, 2001

Last updated: November 1, 2013

Last verified: October 2006

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Methylphenidate Efficacy and Safety in ADHD Preschoolers

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:


Estimated Enrollment:	165
Study Start Date:	April 2001
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

New York State Psychiatric Institute

National Institute of Mental Health (NIMH)

Investigators


Study Chair:	Laurence Greenhill, M.D.

More Information

Additional Information:

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

Publications:

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):1304-13.

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):1284-93. Erratum in: J Am Acad Child Adolesc Psychiatry. 2007 Jan;46(1):141.

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):1314-22.

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):1294-303.

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.

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.


Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00018863 History of Changes
Other Study ID Numbers:	#3761, U01MH060903, U01 MH60642, U01 MH60943, U01 MH60848, U01 MH60900, U01 MH60833, DSIR CT-M2
Study First Received:	July 5, 2001
Last Updated:	November 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:


ADHD

Additional relevant MeSH terms:


Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Methylphenidate Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents	Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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