Non-interventional (NI) Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia

AstraZeneca500 enrolled

Overview

Observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of illness and global improvement in patients using Clinical Global Impression (CGI) scale.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Schizophrenia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with diagnosis of schizophrenia * Patients who are already treated with quetiapine for at least 12 weeks (outpatients or hospitalised patients) * Patients capable of signing ICF Exclusion Criteria: * Patients with hypersensitivity to active substance or any of the excipients of this product * Patients with contraindication for quetiapine therapy according to the approved SmPC

Locations (18)

Research Site

Bjelovar, Croatia

Research Site

Čakovec, Croatia

Research Site

Dubrovnik, Croatia

Outcomes

Primary Outcomes

To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale

Time frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)

Secondary Outcomes

To measure therapeutic response in schizophrenic patients using BPRS scale

Time frame: BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy)

To evaluate compliance with the prescribed antipsychotic treatment

Time frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)

To evaluate prescribing practices for quetiapine in the treatment of schizophrenia in Croatia

Time frame: 3 measures (at the time of quetiapine therapy introduction, after 3 and 6 m of quetiapine therapy)

To evaluate type and frequency of concomitant therapy

Time frame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy

To evaluate average number of hospitalisations

Time frame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in numbers of hospitalisations

To evaluate frequency of mental illnesses in patient's family

Time frame: at visit 1 (day 0)

Data from ClinicalTrials.gov

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