NCT00754208

Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children

Long Acting Stimulant Treatment of ADHD in Young Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

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. Hypotheses 1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children. 2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.

Detailed description

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	methylphenidate	Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.

Timeline

• Start date: 2008-09-18
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-09-17
• Last updated: 2023-10-05
• Results posted: 2018-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study