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

Phase 3
Completed
Conditions
Attention Deficit Disorder With Hyperactivity
Registration Number
NCT00018863
Lead Sponsor
New York State Psychiatric Institute
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).

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
165
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

New York State Psychiatric Institute

🇺🇸

New York, New York, United States

New York University School of Medicine

🇺🇸

New York, New York, United States

University of California, Irvine

🇺🇸

Irvine, California, United States

Johns Hopkins University

🇺🇸

Baltimore, Maryland, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

University of California, Los Angeles

🇺🇸

Los Angeles, California, United States

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