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Clinical Trials/NCT00750087
NCT00750087
Completed
Not Applicable

Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR

AstraZeneca1 site in 1 country578 target enrollmentAugust 2008
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
AstraZeneca
Enrollment
578
Locations
1
Primary Endpoint
Brief Psychiatric Rating Scale - BPRS
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
September 2009
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

Brief Psychiatric Rating Scale - BPRS

Time Frame: monthly/ at every clinic visit- 7 times

Secondary Outcomes

  • 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)
  • Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)(twice/first and last clinic visit)

Study Sites (1)

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