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Long-Duration Stimulant Treatment Study of ADHD in Young Children — B-MPH  

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:
Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis
Clinical Trial Details
NCT number NCT00257725
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 4
Start date March 2005
Completion date March 2008
View Details
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