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Attention Deficit Disorder With HyperactivityPhase 3NCT00018863

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

A Phase 3 study testing Methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by New York State Psychiatric Institute at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 5 years
What is being tested?
Methylphenidate
How many people
165 participants
Where
6 sitesUnited States
Study dates
1 Apr 2001to 30 Nov 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Johns Hopkins University

    Baltimore, Maryland

  • Duke University Medical Center

    Durham, North Carolina

  • University of California, Irvine

    Irvine, California

  • University of California, Los Angeles

    Los Angeles, California

  • New York State Psychiatric Institute

    New York, New York

  • New York University School of Medicine

    New York, New York

Other trials in United States

About this study

Official title: Methylphenidate Efficacy and Safety in ADHD Preschoolers

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).

Read the 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

Being tested
Methylphenidate
Keywords
ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2001 (estimated)
  2. Study start1 Apr 2001
  3. Primary completion31 Mar 2006
  4. Study completion30 Nov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
165 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00018863
Sponsor's protocol ID
#3761
Other IDs
U01MH060903, U01MH060642, U01MH060943, U01MH060848, U01MH060900, U01MH060833, DSIR CT-M2
Status last verified
Nov 2020
First submitted
5 Jul 2001
Last updated
2 Dec 2020
Results posted
No

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. doi: 10.1111/j.1939-0025.1975.tb01164.x.

    PubMed 1089359

  • 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.

    PubMed 10405497

  • 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. doi: 10.1097/00004583-198805000-00012. No abstract available.

    PubMed 3379016

  • 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.

    PubMed 7525394

  • 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.

    PubMed 9334554

  • 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.

    PubMed 17023869

  • 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.

    PubMed 17023868

  • 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.

    PubMed 17023867

  • 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.

    PubMed 17023870

  • 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.

    PubMed 17028508

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by New York State Psychiatric Institute at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00018863, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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