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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302770

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

No publications provided

ClinicalTrials.gov Identifier: NCT00302770     History of Changes
Other Study ID Numbers: D1449C00008
Study First Received: March 13, 2006
Last Updated: January 25, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
Patients with SAD

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014