Quetiapine in Social Anxiety Disorder

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00215254

Enrollment

Registered

2005-09-22

Start date

2004-03-31

Completion date

2006-02-28

Last updated

2006-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder

Keywords

quetiapine, social anxiety disorder, antipsychotic, pilot study

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.

Interventions

DRUGquetiapine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Brief Social Phobia Scale (BSPS)	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026