NCT00606541

An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)

An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
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).
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-12-01
• Completion: 2012-11-01
• First posted: 2008-02-04
• Last updated: 2014-08-01

Locations

1 site across 1 country: United States