Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)
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| ClinicalTrials.gov Identifier: NCT00018863 |
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Recruitment Status : Unknown
Verified October 2006 by New York State Psychiatric Institute.
Recruitment status was: Active, not recruiting
First Posted : July 9, 2001
Last Update Posted : November 4, 2013
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Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Disorder With Hyperactivity | Drug: Methylphenidate | Phase 3 |
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
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 165 participants |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Methylphenidate Efficacy and Safety in ADHD Preschoolers |
| Study Start Date : | April 2001 |
| Actual Primary Completion Date : | March 2006 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Attention-deficit/hyperactivity disorder
Information from the National Library of Medicine
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| Ages Eligible for Study: | 3 Years to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
Investigators
| Study Chair: | Laurence Greenhill, M.D. |
Additional Information:
Publications of Results:
Other 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 |
| Other Study ID Numbers: |
#3761 U01MH060903 ( U.S. NIH Grant/Contract ) U01MH060642 ( U.S. NIH Grant/Contract ) U01MH060943 ( U.S. NIH Grant/Contract ) U01MH060848 ( U.S. NIH Grant/Contract ) U01MH060900 ( U.S. NIH Grant/Contract ) U01MH060833 ( U.S. NIH Grant/Contract ) DSIR CT-M2 |
| First Posted: | July 9, 2001 Key Record Dates |
| Last Update Posted: | November 4, 2013 |
| Last Verified: | October 2006 |
Keywords provided by New York State Psychiatric Institute:
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ADHD |
Additional relevant MeSH terms:
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Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Methylphenidate Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |