Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder
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|ClinicalTrials.gov Identifier: NCT00260533|
Recruitment Status : Completed
First Posted : December 1, 2005
Results First Posted : March 11, 2014
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Generalized Social Phobia||Drug: atomoxetine Drug: placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blind Placebo Controlled Parallel Group Comparison of Atomoxetine (Strattera) for Generalized Social Anxiety Disorder (GSAD)|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Flexible dose, up to 50 mg per day
Other Name: Strattera
Placebo Comparator: 2
placebo (matching to atomoxetine)
- Clinical Global Impression (Change Version, Also Known as Improvement Version) [ Time Frame: 10 weeks (end of study) ]
This is a commonly used, clinician-rated measure of clinical improvement.
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
For purposes of analysis, subjects rated as "(1) Very Much Improved" or "(2) Much Improved" were considered "responders".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260533
|Principal Investigator:||Murray B Stein, M.D.||University of California, San Diego|