Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-30 @ 9:57 AM
Study NCT ID:
NCT00758160
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2008-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Johnson & Johnson Taiwan Ltd
Organization:
Study Overview
Official Title:
From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
Status:
COMPLETED
Status Verified Date:
2014-03
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:
None
Brief Summary:
The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).
Detailed Description:
This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. During the study period, participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ). Safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
False
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?: