Status:
COMPLETED
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
4-5 years
Phase:
PHASE4
Brief Summary
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
Detailed Description
This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00257725
Start Date
March 1 2005
End Date
March 1 2008
Last Update
August 26 2020
Active Locations (1)
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1
New York State Psychiatric Insitute
New York, New York, United States, 10032