Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018863
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2001-07-05
Brief Title:
Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children PATS
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Methylphenidate Efficacy and Safety in ADHD Preschoolers
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research focuses on the treatment of Attention Deficit Hyperactivity Disorder ADHD in very young children The medication being used is methylphenidate Ritalin it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children 3-55 year olds
Detailed Description:
Young children age 3-55 years will be studied The study includes treatment with different doses of methylphenidate and placebo all children will receive active medication during the study Prior to treatment each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop 2 hoursweek Throughout the study parents and teachers will complete forms that report on the childs behavior and possible side effects Participants will be monitored by regular visits with a study physician Most participants will be involved in the study for up to 16 months to ensure optimal evaluation dosing and monitoring
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01MH060903 | NIH | None | None |
| U01MH060642 | NIH | None | None |
| U01MH060943 | NIH | None | None |
| U01MH060848 | NIH | None | None |
| U01MH060900 | NIH | None | None |
| U01MH060833 | NIH | None | None |
| DSIR CT-M2 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01MH060833 |