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Sponsored by: |
Duke University |
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00606541 |
Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.
Condition | Intervention | Phase |
Social Anxiety Disorder |
Drug: Quetiapine XR Drug: Placebo |
Phase IV |
MedlinePlus related topics: | Anxiety |
Drug Information available for: | Quetiapine Quetiapine fumarate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | An Open Label, Double-Blind Discontinuation Study of Quetiapine XR in Social Anxiety Disorder |
Estimated Enrollment: | 55 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Quetiapine XR 50mg-400mg per day
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Drug: Quetiapine XR
This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |||||
Duke University Medical Center | Recruiting | ||||
Durham, North Carolina, United States, 27710 | |||||
Contact: Nabila Lateef 919-684-9701 | |||||
Principal Investigator: Wie Zhang, MD |
Duke University |
Principal Investigator: | Wei Zhang, MD | Duke University |
Responsible Party: | DUMC ( Wei Zhang /Director of Anxiety and PTSD program ) |
Study ID Numbers: | IRUSQUET0452, eIRB2146 |
First Received: | January 22, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00606541 |
Health Authority: | United States: Institutional Review Board |
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