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

EARLY_PHASE1TerminatedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

December 31, 2011

Study Completion Date

November 30, 2012

Conditions
Social Anxiety Disorder
Interventions
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

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT00606541 - An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR) | Biotech Hunter | Biotech Hunter