Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified|
- ADHD-Clinical Global Impression [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.
- The Adult AISRS [ Time Frame: baseline and 6 Weeks ] [ Designated as safety issue: No ]The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.
|Study Start Date:||December 2003|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Experimental: Strattera (atomoxetine)||
Drug: Strattera (atomoxetine)
Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
Other Name: Strattera
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:
- use of a six-week design to document the response rate,
- weekly assessments to document the impact of Strattera NOS on functional capacities,
- careful assessment of safety and tolerability.
Primary outcomes measure symptom reduction.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|