Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
Recruitment status was: Recruiting
This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic development in a significant portion of young children with ADHD. This would be one of the first studies looking at a long-acting preparation of a stimulant medication in the treatment of ADHD in very young children.
- Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.
- Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Long Acting Stimulant Treatment of ADHD in Young Children|
- The primary outcome measure for the study will be the change in ADHD-IV total score. [ Time Frame: Weekly for the first month. Biweekly for the second month. ] [ Designated as safety issue: No ]
- The secondary outcome measures will be the CGAS, CGI-improvement and CGI-severity taken pre and post-study duration as well as the change in ADHD-IV subtype total scores. [ Time Frame: Weekly for the first month and biweekly for the second month ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- Ritalin LA
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754208
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-5584|
|Principal Investigator:||Joan Daughton, MD||University of Nebraska|