Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
|ClinicalTrials.gov Identifier: NCT00181766|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : June 23, 2010
Last Update Posted : December 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|ADHD NOS||Drug: Strattera (atomoxetine)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
|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
- ADHD-Clinical Global Impression [ Time Frame: 6 Weeks ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181766
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|