Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181571
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
2005-09-13
Brief Title:
A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This is a double-blind placebo-controlled study using daily doses of up to 13 mgkgday of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder ADHD childhood onset We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time
Detailed Description:
Concerta was specially developed to replace three-times-a-day IR methylphenidate making it an ideal option for patients with ADHD Moreover the once-a-day administration of Concerta secures a steady delivery of methylphenidate across the day minimizing the well-known risks of peaks and valleys of IR methylphenidate which could offer an added advantage to the pharmacokinetic advantage of once-a-day administration Despite these putative advantages whether this new delivery system will lead to the same results as those documented with immediate-response methylphenidate in the treatments of adults with ADHD requires empirical corroboration To this end we are conducting a randomized controlled clinical trial to evaluate the short- and medium-term safety and efficacy of Concerta in the treatment of adults with ADHD with and without co-morbid psychiatric disorders We also wish to examine the role of genetics in predicting ADHD treatment response to Concerta There is growing literature that supports the role of genetic factors in treatment response in youth with ADHD and we seek to further explore this relationship in adults
The proposed study includes the use of a 34-week design to document the response rate assessment of the impact of Concerta on functional capacities quality of life psychosocial function and cognition and careful assessment of safety and tolerability
The proposed study includes the use of a 34-week design to document the response rate assessment of the impact of Concerta on functional capacities quality of life psychosocial function and cognition and careful assessment of safety and tolerability
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