Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)
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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 |
| Estimated Enrollment: | 165 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | August 2004 |
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 |
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| 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 | |
| Study Chair: | Laurence Greenhill, M.D. |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00018863 History of Changes |
| Other Study ID Numbers: | U01 MH60903, U01 MH60642, U01 MH60943, U01 MH60848, U01 MH60900, U01 MH60833, DSIR CT-M2 |
| Study First Received: | July 5, 2001 |
| Last Updated: | June 26, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Mental Health (NIMH):
|
ADHD |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013