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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:
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
  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:


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
Investigators
Study Chair: Laurence Greenhill, M.D.
  More Information

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

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
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
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 November 23, 2014