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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-11-30

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.

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Detailed Description

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Conditions

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Quetiapine XR 50mg-400mg per day

Group Type EXPERIMENTAL

Quetiapine XR

Intervention Type DRUG

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).

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Quetiapine XR

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).

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Seroquel XR

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No