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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00981123

Enrollment

500

Registered

2009-09-22

Start date

2009-09-30

Completion date

2010-04-30

Last updated

2011-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 measure therapeutic response in schizophrenic patients using BPRS scale	BPRS - 2 measures (after 3 and after 6 months of quetiapine 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)
To evaluate type and frequency of concomitant therapy	At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy

Countries

Croatia

Outcome results