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

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Social Anxiety Disorder

In brief

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.

Key facts

Study ID: NCT00606541
Run by: Duke University
People needed: 55
Starts: 2008-01-01
Expected to finish: 2012-11-01
Last updated by the study team: 2014-08-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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