Efficacy of Quetiapine in Generalised Social Anxiety Disorder

This study has been terminated.

(This study was terminated due to poor enrollment)

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00302770

First received: March 13, 2006

Last updated: January 25, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2006

Last Updated Date

January 25, 2011

Start Date ^ICMJE

June 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00302770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of responders, time to onset of response of sustained response to treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy of Quetiapine in Generalised Social Anxiety Disorder

Official Title ^ICMJE

Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study

Brief Summary

This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Social Anxiety Disorder

Intervention ^ICMJE

Drug: quetiapine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written Confirmed Consent,
All patients meet the DSM IV criteria for generalized social anxiety disorder,
A score ≥ 60 on the LSAS,
male and female aged between 18 and 65 years

Exclusion Criteria:

Presence of any primary axis I diagnosis other than social anxiety disorder according to DSM-IV,
alcohol and/or substance abuse according to DSM-IV criteria within the last 12 months,
any personality disorder as the primary diagnosis, with the exception of avoidant personality disorder,
patients at risk of suicide

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00302770

Other Study ID Numbers ^ICMJE

D1449C00008

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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