Seroquel (Quetiapine Fumarate) InPractice Evaluation Prog... | NCT00921362

Studies
Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

NCT00921362

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 16, 2009Estimated

Enrollment

1,387Actual

Phase

Not provided

Conditions

Schizophrenia

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
SER-01-S-06

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Jun 15, 2009

First Submission Date that Met QC Criteria

Jun 15, 2009

First Posted Date

Jun 16, 2009Estimated

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

Jun 15, 2009

Last Update Posted Date

Jun 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,387Actual

Label	Type	Description	Intervention Names
1		Schizophrenia patients under Seroquel treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brief Psychiatric Rating Scale - BPRS		Monthly at every clinic visit- 7 times

Secondary Outcomes

Measure	Description	Time Frame
Clinical Global Impression Severity of Illness		Monthly/ at every clinic visit-7 times
CGI-S Clinical Global Impression Improvement CGI -I		Monthly/ at every clinic visit except first visit- 6 times

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale
To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool

Exclusion Criteria:

All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients eligible for entry into the study will have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature

Sampling Method

Probability Sample

Name	Affiliation	Role
stina Pentiuc, Med Director	AstraZeneca Romania	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided