NCT00018863

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2001

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2001

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2006

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

5 years

First QC Date

July 5, 2001

Last Update Submit

November 30, 2020

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD

Interventions

MethylphenidateDRUG

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

University of California, Irvine

Irvine, California, United States

Location

University of California, Los Angeles

Los Angeles, California, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

New York State Psychiatric Institute

New York, New York, United States

Location

New York University School of Medicine

New York, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Related Publications (11)

  • 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.

    PMID: 1089359BACKGROUND

  • 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.

    PMID: 10405497BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 3379016BACKGROUND

  • 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.

    PMID: 7525394BACKGROUND

  • 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.

    PMID: 9334554BACKGROUND

  • 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.

    PMID: 17023869RESULT

  • 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.

    PMID: 17023868RESULT

  • 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.

    PMID: 17023867RESULT

  • 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.

    PMID: 17023870RESULT

  • 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.

    PMID: 17028508RESULT

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Laurence Greenhill, M.D.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Child and Adolescent Psychiatry

Study Record Dates

First Submitted

July 5, 2001

First Posted

July 9, 2001

Study Start

April 1, 2001

Primary Completion

March 31, 2006

Study Completion

November 30, 2006

Last Updated

December 2, 2020

Record last verified: 2020-11

Locations

US(6)