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

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Social Anxiety Disorder

Intervention: Quetiapine XR (Drug); Placebo (Drug)

Phase: Phase 0

Status: Terminated

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Wei Zhang, MD, Principal Investigator, Affiliation: Duke University


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)

Secondary outcome: Percentage of CGI-I, BSPS, SPIN


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- Subjects needing concurrent use of psychotropic medications

- History of hypersensitivity to quetiapine

- History of cataracts.

Locations and Contacts

Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information

Starting date: January 2008
Last updated: July 31, 2014

Page last updated: August 23, 2015

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