Non-interventional Study -Observe Treatment Efficacy in M... | NCT00750087

Status Module

Record Verification Date

Feb 2010

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

Aug 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Sep 9, 2008

First Submission Date that Met QC Criteria

Sep 9, 2008

First Posted Date

Sep 10, 2008Estimated

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

Feb 4, 2010

Last Update Posted Date

Feb 5, 2010Estimated

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

the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

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

578Actual

Label	Type	Description	Intervention Names
1		Schizophrenia patients stabilized on Seroquel XR

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 - CGI -S		monthly/ at every clinic visit- 7 times
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:

Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before
All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.

Exclusion Criteria:

All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.

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

The programme will include schizophrenia patients stabilized on Seroquel XR from community sample

Sampling Method

Probability Sample

Name	Affiliation	Role
Beatrice Costea	AstraZeneca	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Alba			Romania
Research Site

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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