This trial is active, not recruiting.

Condition attention deficit disorder with hyperactivity
Treatment methylphenidate
Phase phase 3
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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Masking double-blind
Primary purpose treatment

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.