Long-Duration Stimulant Treatment Study of ADHD in Young Children

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

1. Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.

2. Boys and girls from 4-5 years old (inclusive) at screening.

3. 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.

4. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.

5. Children with IQ of at least 70 confirmed by valid IQ test.

6. 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.

7. Parents and children who can attend weekly study visits.

8. 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 Criteria:

1. 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.

2. Children taking excluded medications.

3. Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.

4. Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.

5. Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.

6. Children with screening abnormalities deemed clinically significant by child psychiatrist.