Efficacy of Quetiapine in Generalised Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302770
Recruitment Status : Terminated (This study was terminated due to poor enrollment)
First Posted : March 15, 2006
Last Update Posted : January 27, 2011
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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

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: quetiapine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study
Study Start Date : June 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Primary Outcome Measures :
  1. Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint

Secondary Outcome Measures :
  1. Number of responders, time to onset of response of sustained response to treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00302770

Research Site
Utrecht, Netherlands
Sponsors and Collaborators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca Identifier: NCT00302770     History of Changes
Other Study ID Numbers: D1449C00008
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Patients with SAD

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs