Trials / Completed
CompletedNCT00257725
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- New York State Psychiatric Institute · Academic / Other
- Sex
- All
- Age
- 4 Years – 5 Years
- Healthy volunteers
- Accepted
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 older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children. Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | B-MPH | Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days |
Timeline
- Start date
- 2005-03-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2005-11-23
- Last updated
- 2020-08-26
- Results posted
- 2020-08-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00257725. Inclusion in this directory is not an endorsement.