Quetiapine in Social Anxiety Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-02-28

Brief Summary

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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

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This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.

Conditions

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Social Anxiety Disorder

Keywords

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quetiapine social anxiety disorder antipsychotic pilot study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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quetiapine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jonathan Davidson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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5639-04-3R0

Identifier Type: -

Identifier Source: org_study_id