search
Back to results

Quetiapine in Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
quetiapine
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring quetiapine, social anxiety disorder, antipsychotic, pilot study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult outpatients 18-65 years of age primary diagnosis of social anxiety disorder, using DSM-IV criteria minimum CGI severity score of 4 at baseline minimum BSPS score of 20 at baseline written informed consent negative serum pregnancy test for women of childbearing potential Exclusion Criteria: current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic 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 with 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 concomitant medication use for psychotropic purposes history of hypersensitivity to quetiapine

Sites / Locations

  • Duke University Medical Center

Outcomes

Primary Outcome Measures

Brief Social Phobia Scale (BSPS)

Secondary Outcome Measures

Clinical Global Impressions of Severity (CGI-S)
Clinical Global Impressions of Improvement (CGI-I)
Social Phobia Inventory (SPIN)
Hospital Anxiety and Depression Scale (HADS)
Connor Davidson Resilience Scale (CD-RISC)
Sheehan Disability Inventory (SDI)
Barnes Akathisis Scale (BAS)
Simpson-Angus Scale (SAS)

Full Information

First Posted
September 20, 2005
Last Updated
December 18, 2006
Sponsor
Duke University
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00215254
Brief Title
Quetiapine in Social Anxiety Disorder
Official Title
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.
Detailed Description
This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
quetiapine, social anxiety disorder, antipsychotic, pilot study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
quetiapine
Primary Outcome Measure Information:
Title
Brief Social Phobia Scale (BSPS)
Secondary Outcome Measure Information:
Title
Clinical Global Impressions of Severity (CGI-S)
Title
Clinical Global Impressions of Improvement (CGI-I)
Title
Social Phobia Inventory (SPIN)
Title
Hospital Anxiety and Depression Scale (HADS)
Title
Connor Davidson Resilience Scale (CD-RISC)
Title
Sheehan Disability Inventory (SDI)
Title
Barnes Akathisis Scale (BAS)
Title
Simpson-Angus Scale (SAS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult outpatients 18-65 years of age primary diagnosis of social anxiety disorder, using DSM-IV criteria minimum CGI severity score of 4 at baseline minimum BSPS score of 20 at baseline written informed consent negative serum pregnancy test for women of childbearing potential Exclusion Criteria: current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic 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 with 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 concomitant medication use for psychotropic purposes history of hypersensitivity to quetiapine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Davidson, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Quetiapine in Social Anxiety Disorder

We'll reach out to this number within 24 hrs