Efficacy of Quetiapine in Generalised Social Anxiety Diso... | NCT00302770

Studies
Efficacy of Quetiapine in Generalised Social Anxiety Disorder

NCT00302770

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Jan 27, 2011Estimated

Enrollment

50Estimated

Phase

Phase 3

Conditions

Social Anxiety Disorder

Interventions

quetiapine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was terminated due to poor enrollment

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Mar 13, 2006

First Submission Date that Met QC Criteria

Mar 13, 2006

First Posted Date

Mar 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2011

Last Update Posted Date

Jan 27, 2011Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
quetiapine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint

Secondary Outcomes

Measure	Description	Time Frame
Number of responders, time to onset of response of sustained response to treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca Netherlands Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Utrecht			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D000072861	Phobia, Social

Ancestor Terms

ID	Term
D010698	Phobic Disorders
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069348	Quetiapine Fumarate

Ancestor Terms

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided