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

Duke University logo

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

55 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Quetiapine XR 50mg-400mg per day
Treatment:
Drug: Quetiapine XR
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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