Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00690365
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a single-arm, phase IV, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved SPC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
Inclusion Criteria
- Diagnosis of schizophrenia at least 1 year prior to screening
- Inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication
- Provision of Informed Consent prior to enrolment
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Exclusion Criteria
- Known hypersensitivity to active substance of excipients
- Patients receiving P450 3A4 inhibitors
- Pregnancy or lactation
- Substance abuse or dependence
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of quetiapine assessed through analysis of AE/SAE data (rate of patients presenting SAEs, rate of patients who discontinue treatment due to any AE, time to treatment discontinuation due to any AEs) 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period
- Secondary Outcome Measures
Name Time Method Changes in the Clinical Global Impression of Severity and Improvement (CGI-S, CGI-I) and in Brief psychiatric Rating Scale (BPRS) from baseline to end of study treatment 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24) Percentage of extra-pyramidal side effects assessed using the Simpson-Angus Scale (SAS) Changes from baseline to end of study treatment or (6 months) or early withdrawal