A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified
Sponsor study identifier
interventional
45
1 country
1
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 16, 2005
Actual (reported)July 2008
Actual (reported)July 2008
Actual (reported)June 23, 2010
Actual (reported)ADHD-Clinical Global Impression
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.
6 Weeks
The Adult AISRS
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.
baseline and 6 Weeks
Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
* small, open label study * short exposure to medication
Janet Wozniak, MD
Massachusetts General Hospital
45 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
August 21, 2019
Results First Posted
June 23, 2010
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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