Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia

AstraZeneca576 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

576

Conditions

Schizophrenia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Time frame: 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)

Time frame: Changes from baseline to end of study treatment or (6 months) or early withdrawal

Data from ClinicalTrials.gov

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