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

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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606541

Enrollment

Registered

2008-02-04

Start date

2008-01-31

Completion date

2012-11-30

Last updated

2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder, Quetiapine XR, Prevention, tolerability

Brief summary

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.

Interventions

DRUGQuetiapine 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).

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)	20 weeks

Secondary

Measure	Time frame
Percentage of CGI-I, BSPS, SPIN	20 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026