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

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Quetiapine Fumarate

Criteria

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.