Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257725
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2005-11-21
Brief Title:
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B-MPH
Brief Summary:
This study will evaluate if Ritalin LA is safe and effective for ADHD treatment in 4-to-5-year olds
Detailed 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-deficithyperactivity 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None