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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of California, Irvine
  • University of California, Los Angeles
  • Johns Hopkins University
  • New York State Psychiatric Institute
  • New York University School of Medicine
  • Duke University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2001
Last Updated
November 30, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00018863
Brief Title
Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)
Official Title
Methylphenidate Efficacy and Safety in ADHD Preschoolers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2001 (Actual)
Primary Completion Date
March 31, 2006 (Actual)
Study Completion Date
November 30, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
165 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methylphenidate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Greenhill, M.D.
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1089359
Citation
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. doi: 10.1111/j.1939-0025.1975.tb01164.x.
Results Reference
background
PubMed Identifier
10405497
Citation
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. doi: 10.1097/00004583-199907000-00009.
Results Reference
background
Citation
Conners CK: Controlled trial of methylphenidate in preschool children with minimal brain dysfunction. Int J Ment Health (4):61-74, 1975.
Results Reference
background
PubMed Identifier
3379016
Citation
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. doi: 10.1097/00004583-198805000-00012. No abstract available.
Results Reference
background
PubMed Identifier
7525394
Citation
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. doi: 10.1111/j.1469-8749.1994.tb11811.x.
Results Reference
background
PubMed Identifier
9334554
Citation
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. doi: 10.1097/00004583-199710000-00023.
Results Reference
background
PubMed Identifier
17023869
Citation
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):1275-1283. doi: 10.1097/01.chi.0000235074.86919.dc.
Results Reference
result
PubMed Identifier
17023868
Citation
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. doi: 10.1097/01.chi.0000235075.25038.5a.
Results Reference
result
PubMed Identifier
17023867
Citation
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. doi: 10.1097/01.chi.0000235077.32661.61. Erratum In: J Am Acad Child Adolesc Psychiatry. 2007 Jan;46(1):141.
Results Reference
result
PubMed Identifier
17023870
Citation
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. doi: 10.1097/01.chi.0000235083.40285.08.
Results Reference
result
PubMed Identifier
17028508
Citation
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. doi: 10.1097/01.chi.0000235082.63156.27.
Results Reference
result
Links:
URL
http://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml
Description
Specific information on ADHD

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

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