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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Methylphenidate Efficacy and Safety in ADHD Preschoolers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018863
• Other study ID #: #3761
• Secondary ID: U01MH060903U01MH
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2001
• Est. completion date: November 30, 2006

Study information

• Verified date: November 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 30, 2006
• Est. primary completion date: March 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Methylphenidate

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California, Irvine	Irvine	California
United States	University of California, Los Angeles	Los Angeles	California
United States	New York State Psychiatric Institute	New York	New York
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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

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 fo — View 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. — View 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 A — View 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. — View 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 i — View 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. — View 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. — View 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 — View 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 — View Citation

* Note: There are 11 references in all — Click here to view all references

External Links

•   Specific information on ADHD