Back to resultsEfficacy of Quetiapine in Generalised Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Patients with SAD
Eligibility 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
Sites / Locations
- Research Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00302770
Brief Title
Efficacy of Quetiapine in Generalised Social Anxiety Disorder
Official Title
Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to poor enrollment
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Patients with SAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
quetiapine
Primary Outcome Measure Information:
Title
Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint
Secondary Outcome Measure Information:
Title
Number of responders, time to onset of response of sustained response to treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Netherlands Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Utrecht
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Quetiapine in Generalised Social Anxiety Disorder
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