Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
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|ClinicalTrials.gov Identifier: NCT00754208|
Recruitment Status : Unknown
Verified May 2009 by University of Nebraska.
Recruitment status was: Recruiting
First Posted : September 17, 2008
Last Update Posted : June 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: methylphenidate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long Acting Stimulant Treatment of ADHD in Young Children|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||August 2009|
- Ritalin LA
- 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. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754208
|Contact: Joan Daughton, MDemail@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198-5584|
|Contact: Joan Daughton, MD 402-552-6006 firstname.lastname@example.org|
|Principal Investigator:||Joan Daughton, MD||University of Nebraska|