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

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00606541
• Other study ID #: Pro00002146
• Secondary ID: eIRB2146IRUSQUET
• Status: Terminated
• Phase: Phase 0
• First received: January 22, 2008
• Last updated: July 31, 2014
• Start date: January 2008
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: November 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

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).
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)		20 weeks	Yes
Secondary	Percentage of CGI-I, BSPS, SPIN		20 weeks	Yes