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NCT00302770 Clinical Trial

Efficacy of Quetiapine in Generalised Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00302770
Other study ID # D1449C00008
Secondary ID
Status Terminated
Phase Phase 3
First received March 13, 2006
Last updated January 25, 2011
Start date June 2006
Est. completion date December 2006

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• quetiapine

Locations
Country Name City State
Netherlands Research Site Utrecht

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint
Secondary Number of responders, time to onset of response of sustained response to treatment
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