Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00750087
- Lead Sponsor
- AstraZeneca
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 578
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.
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brief Psychiatric Rating Scale - BPRS monthly/ at every clinic visit- 7 times
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇷🇴Zalau, Romania