Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181740
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2005-09-13
Brief Title:
Concerta Treatment in Adults With ADHD NOS
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Pilot Study of Concerta Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified
Status:
COMPLETED
Status Verified Date:
2010-07
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 will be an open label pilot study of Concerta in the treatment of adults with the diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified ADHD NOS We hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta treatment in the short term and Concerta-associated response of ADHD symptomatology in adults with ADHD NOS will be sustained over the medium term
Detailed Description:
Concerta is a stimulant medication approved for the treatment of ADHD in children We propose to study the safety and efficacy of Concerta therapy in adults with ADHD NOS Adult ADHD NOS is operationalized by either
An adult satisfying current diagnostic criteria for ADHD but with insufficient number of childhood symptoms to fulfill the required diagnostic threshold for this disorder set forth in DSM-IV
An adult who has five current symptoms of inattention andor five current symptoms of impulsivityhyperactivity but does not meet the full diagnosis criteria of six current symptoms within one of these categories
Our hypotheses will be examined in two phases of an open label pilot study Phase I of the study consists of a six-week acute effectiveness trial Phase II consists of continuation for responders in which subjects who respond in Phase I will be re-assessed every four weeks for six months Effectiveness will be measured by improvements in clinician-rated scales including ADHD Symptom Checklist Clinical Global Impression ADHD and Global Assessment of Functioning
An adult satisfying current diagnostic criteria for ADHD but with insufficient number of childhood symptoms to fulfill the required diagnostic threshold for this disorder set forth in DSM-IV
An adult who has five current symptoms of inattention andor five current symptoms of impulsivityhyperactivity but does not meet the full diagnosis criteria of six current symptoms within one of these categories
Our hypotheses will be examined in two phases of an open label pilot study Phase I of the study consists of a six-week acute effectiveness trial Phase II consists of continuation for responders in which subjects who respond in Phase I will be re-assessed every four weeks for six months Effectiveness will be measured by improvements in clinician-rated scales including ADHD Symptom Checklist Clinical Global Impression ADHD and Global Assessment of Functioning
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