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
This protocol involves an 8-week, open-label, 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. The purpose of this study is to ascertain pilot data on the use of long-acting stimulants in preschool-age children since virtually no data exist on these medications in this population. The interventions include utilizing short-acting methylphenidate for the initial dosing and titration and then converting the children to Ritalin LA once an optimal dose has been found. Parents will also be receiving parent education training throughout the study. Evaluations will include obtaining the ADHD-IV at every visit, side effects of the medication, vital signs, EKG, physical exam, the Clinical Global Assessment Scale, and the Clinical Global Impression-Improvement and Severity Scales. This study will also assess parent stress with the Parent Stress Index and the emotional index of the children with the Expressed Emotion Scale for Children. Follow-up will be weekly during the first month and bi-weekly during the second month.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754208
|Contact: Joan Daughton, MDfirstname.lastname@example.org|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198-5584|
|Contact: Joan Daughton, MD 402-552-6006 email@example.com|
|Principal Investigator:||Joan Daughton, MD||University of Nebraska|