NCT00215254

Brief Summary

The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

December 19, 2006

Status Verified

March 1, 2006

First QC Date

September 20, 2005

Last Update Submit

December 18, 2006

Conditions

Social Anxiety Disorder

Keywords

quetiapinesocial anxiety disorderantipsychoticpilot study

Outcome Measures

Primary Outcomes (1)

  • Brief Social Phobia Scale (BSPS)

Secondary Outcomes (8)

  • Clinical Global Impressions of Severity (CGI-S)

  • Clinical Global Impressions of Improvement (CGI-I)

  • Social Phobia Inventory (SPIN)

  • Hospital Anxiety and Depression Scale (HADS)

  • Connor Davidson Resilience Scale (CD-RISC)

  • +3 more secondary outcomes

Interventions

quetiapineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult outpatients 18-65 years of age
  • primary diagnosis of social anxiety disorder, using DSM-IV criteria
  • minimum CGI severity score of 4 at baseline
  • minimum BSPS score of 20 at baseline
  • written informed consent
  • negative serum pregnancy test for women of childbearing potential

You may not qualify if:

  • current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic 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 with 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
  • concomitant medication use for psychotropic purposes
  • history of hypersensitivity to quetiapine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jonathan Davidson, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

March 1, 2004

Study Completion

February 1, 2006

Last Updated

December 19, 2006

Record last verified: 2006-03

Locations

US(1)