Long Duration Stimulant Treatment Study of Preschoolers With ADHD-Feasibility Study
|Attention Deficit Disorder With Hyperactivity||Drug: Ritalin LA™||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Study Start Date:||March 2005|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257725
|United States, New York|
|New York State Psychiatric Insitute|
|New York, New York, United States, 10032|
|Principal Investigator:||Laurence L Greenhill, MD||New York State Psychiatric Insitute|