At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 11 enrolled
Drug / intervention
B-MPHdrug
Likely dose
B-methylphenidate 20 mg once daily in the morningAI-extracted
Key inclusion· 7
- ✓Children aged 4-5 years old at screening
- ✓Meet DSM-IV criteria for ADHD (combined or hyperactive subtype) with symptoms present ≥9 months
- ✓Adequate need for ADHD treatment based on symptom severity and clinical impairment
- ✓IQ of at least 70 confirmed by valid IQ test
Key exclusion· 5
- ✕History of intolerance to MPH/stimulant medications or no response to adequate stimulant trials
- ✕Current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders
- ✕History of physical, sexual, or emotional abuse with significant clinical impact on ADHD presentation
- ✕Screening abnormalities deemed clinically significant by child psychiatrist
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
In Brief
A Phase 4 clinical trial evaluating B-MPH for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 11 participants across 1 site.
Detailed Summary
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedNov 2005
Primary CompletionMar 2008
TodayJul 2026
First PostedNov 23, 2005
Enrollment StartMar 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.6 years ago
Interventions
B-MPHdrug
Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days