Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)
This trial is active, not recruiting.
|Condition||attention deficit disorder with hyperactivity|
|Sponsor||New York State Psychiatric Institute|
|Collaborator||National Institute of Mental Health (NIMH)|
|Start date||April 2001|
|End date||March 2006|
|Trial size||165 participants|
|Trial identifier||NCT00018863, #3761, DSIR CT-M2, U01 MH60642, U01 MH60833, U01 MH60848, U01 MH60900, U01 MH60943, U01MH060903|
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).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Irvine, CA||University of California, Irvine||no longer recruiting|
|Los Angeles, CA||University of California, Los Angeles||no longer recruiting|
|Baltimore, MD||Johns Hopkins University||no longer recruiting|
|New York, NY||New York State Psychiatric Institute||no longer recruiting|
|New York, NY||New York University School of Medicine||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
Male or female participants from 3 years up to 5 years old.
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
|Official title||Methylphenidate Efficacy and Safety in ADHD Preschoolers|
|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|
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