NCT00750087
Completed
Not Applicable
Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR
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.
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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