NCT00302770

Brief Summary

This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

March 13, 2006

Last Update Submit

January 25, 2011

Conditions

Social Anxiety Disorder

Keywords

Patients with SAD

Outcome Measures

Primary Outcomes (1)

  • Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint

Secondary Outcomes (1)

  • Number of responders, time to onset of response of sustained response to treatment

Interventions

quetiapineDRUG

Eligibility Criteria

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

You may qualify if:

  • Written Confirmed Consent,
  • All patients meet the DSM IV criteria for generalized social anxiety disorder,
  • A score ≥ 60 on the LSAS,
  • male and female aged between 18 and 65 years

You may not qualify if:

  • Presence of any primary axis I diagnosis other than social anxiety disorder according to DSM-IV,
  • alcohol and/or substance abuse according to DSM-IV criteria within the last 12 months,
  • any personality disorder as the primary diagnosis, with the exception of avoidant personality disorder,
  • patients at risk of suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Utrecht, Netherlands

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

  • AstraZeneca Netherlands Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 15, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

NL(1)