Phase 4
Completed N=11
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00257725 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) — -1.09 score on a scale — p=0.01
◆ Published Evidence
Established
26citations · ~2 / year
The open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidate.
Summary
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
Linked Publications
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The open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) |
-1.09 | 0.01 sig |
| PRIMARY Clinical Global Impressions-Severity (CGI-S) |
-1.64 | 0.01 sig |
| PRIMARY Children's Global Assessment Scale (C-GAS) |
10.55 | 0.01 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00257725) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.