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Efficacy of Quetiapine in Generalised Social Anxiety Disorder

This study has been terminated.
(This study was terminated due to poor enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302770
First Posted: March 15, 2006
Last Update Posted: January 27, 2011
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Social Anxiety Disorder Drug: quetiapine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 50
Study Start Date: June 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00302770


Locations
Netherlands
Research Site
Utrecht, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00302770     History of Changes
Other Study ID Numbers: D1449C00008
First Submitted: March 13, 2006
First Posted: March 15, 2006
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Patients with SAD

Additional relevant MeSH terms:
Disease
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