An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)

Study Overview
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Brief Summary
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Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.

Official Title
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An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: Quetiapine XR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-65 years of age A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline Written informed consent A negative serum pregnancy test for women of childbearing potential. Exclusion Criteria: Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition Any current primary anxiety disorder other than SAD or current primary depression History of substance abuse or dependence within the last 6 months Suicide risk or serious suicide attempt within the last year Clinically significant medical condition or laboratory abnormality Women of childbearing potential who are unwilling to practice an acceptable method of contraception Subjects needing concurrent use of psychotropic medications History of hypersensitivity to quetiapine History of cataracts.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Quetiapine XR 50mg-400mg per day | Drug: Quetiapine XR<br>* This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).<br>* Other names: Seroquel XR;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I) |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of CGI-I, BSPS, SPIN |  | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Anxiety Disorder, Quetiapine XR, Prevention, tolerability