Long-Duration Stimulant Treatment Study of ADHD in Young Children

Completed · Phase 4

Conditions studied: Attention Deficit Disorder With Hyperactivity

In brief

This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.

Key facts

Study ID

NCT00257725

Run by

New York State Psychiatric Institute

People needed

11

Starts

2005-03-01

Expected to finish

2008-03-01

Last updated by the study team

2020-08-26

Who can join

Age: 4 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.
• Boys and girls from 4-5 years old (inclusive) at screening.
• Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months.
• Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.
• Children with IQ of at least 70 confirmed by valid IQ test.
• Children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly.
• Parents and children who can attend weekly study visits.
• Children who are naïve to ADHD medications; received ADHD medications in the past but are not currently treated; or on ADHD medications but finding them inconvenient (due to short duration of action) or not very helpful

You may not qualify if…

• Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist.
• Children taking excluded medications.
• Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.
• Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.
• Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.
• Children with screening abnormalities deemed clinically significant by child psychiatrist.

Where it is running

• New York State Psychiatric Insitute — New York, New York, United States

Full record on ClinicalTrials.gov

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