A Non-interventional, Open Label, Phase IV Observational Study for the Safety and Efficacy of Switching to Quetiapine (Seroquel) in Outpatients With Schizophrenia Who Have Been Unsuccessfully Treated With Other Antipsychotics

AstraZeneca0 sites576 target enrollmentJune 2007

ConditionsSchizophrenia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: AstraZeneca
Enrollment: 576
Primary Endpoint: 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)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

April 2008

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Exclusion Criteria

•Known hypersensitivity to active substance of excipients
•Patients receiving P450 3A4 inhibitors
•Pregnancy or lactation
•Substance abuse or dependence

Outcomes

Primary Outcomes

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)

Time Frame: 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period

Secondary Outcomes

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)