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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00981123
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-07
• Last Update Posted: 2011-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale	CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)

Secondary Outcome Measures

Name	Time	Method
To measure therapeutic response in schizophrenic patients using BPRS scale	BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy)
To evaluate compliance with the prescribed antipsychotic treatment	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	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	At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy
To evaluate average number of hospitalisations	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	at visit 1 (day 0)

Trial Locations

Locations (1)

Research Site; 🇭🇷 Zagreb, Croatia