Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-01 @ 8:40 PM
Study NCT ID:
NCT00181766
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
Sponsor:
Massachusetts General Hospital
Organization:
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 mg/day 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 mg/day or 1.5 mg/kg/day, 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:
True
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?: