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

Duke University

Status and phase

Terminated

Early Phase 1

Conditions

Social Anxiety Disorder

Treatments

Drug: Quetiapine XR

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00606541

eIRB2146

IRUSQUET0452

Pro00002146

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.