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

Early Phase 1

Terminated

• Conditions: Social Anxiety Disorder
• Interventions: Drug: Quetiapine XR; Drug: Placebo

• Registration Number: NCT00606541
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-04
• Primary Completion: 2011-12
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Adults 18-65 years of age
• A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria
• Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
• Written informed consent
• A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria

• Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
• Any current primary anxiety disorder other than SAD or current primary depression
• History of substance abuse or dependence within the last 6 months
• Suicide risk or serious suicide attempt within the last year
• Clinically significant medical condition or laboratory abnormality
• Women of childbearing potential who are unwilling to practice an acceptable method of contraception
• Subjects needing concurrent use of psychotropic medications
• History of hypersensitivity to quetiapine
• History of cataracts.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Quetiapine XR	Quetiapine XR 50mg-400mg per day
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)	20 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of CGI-I, BSPS, SPIN	20 weeks

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States