Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181766
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2005-09-13
Brief Title:
Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified ADHD NOS
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified
Status:
COMPLETED
Status Verified Date:
2019-08
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:
None
Brief Summary:
This is an open-label study with daily doses up to 144 mgday Strattera atomoxetine in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Strattera treatment and Strattera treatment in doses of up to 120 mgday or 15 mgkgday whichever is less in adults with ADHD NOS will be safe and well tolerated
Detailed Description:
Strattera atomoxetine is a non-stimulant specific norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for the treatment of child adolescent and adult patients with ADHD It is possible Strattera could be a viable alternative treatment for ADHD individuals The purpose of this study is to assess the effectiveness safety and tolerability of Strattera in adults with ADHD NOS If this initial study shows promise we will follow-up with a randomized clinical trial
The study includes
1 use of a six-week design to document the response rate
2 weekly assessments to document the impact of Strattera NOS on functional capacities
3 careful assessment of safety and tolerability
Primary outcomes measure symptom reduction
The study includes
1 use of a six-week design to document the response rate
2 weekly assessments to document the impact of Strattera NOS on functional capacities
3 careful assessment of safety and tolerability
Primary outcomes measure symptom reduction
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