Clinical trial NCT00981123: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients or hospitalised patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale
timeFrame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)
Secondary outcomes:
measure: To measure therapeutic response in schizophrenic patients using BPRS scale
timeFrame: BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy)
measure: To evaluate compliance with the prescribed antipsychotic treatment
timeFrame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)
measure: To evaluate prescribing practices for quetiapine in the treatment of schizophrenia in Croatia
timeFrame: 3 measures (at the time of quetiapine therapy introduction, after 3 and 6 m of quetiapine therapy)
measure: To evaluate type and frequency of concomitant therapy
timeFrame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy
measure: To evaluate average number of hospitalisations
timeFrame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in numbers of hospitalisations
measure: To evaluate frequency of mental illnesses in patient's family
timeFrame: at visit 1 (day 0)
Other outcomes:
Locations:
city: Bjelovar
country: Croatia
facility: Research Site
city: Cakovec
country: Croatia
facility: Research Site
city: Dubrovnik
country: Croatia
facility: Research Site
city: Karlovac
country: Croatia
facility: Research Site
city: Osijek
country: Croatia
facility: Research Site
city: Popovaca
country: Croatia
facility: Research Site
city: Pula
country: Croatia
facility: Research Site
city: Rijeka
country: Croatia
facility: Research Site
city: Sibenik
country: Croatia
facility: Research Site
city: Sisak
country: Croatia
facility: Research Site
city: Slavonski brod
country: Croatia
facility: Research Site
city: Split
country: Croatia
facility: Research Site
city: Varazdin
country: Croatia
facility: Research Site
city: Vinkovci
country: Croatia
facility: Research Site
city: Vukovar
country: Croatia
facility: Research Site
city: Zabok
country: Croatia
facility: Research Site
city: Zadar
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
Study officials:
affiliation: AstraZeneca Medical Department
name: Ana Marija Gjurovic, MD, MSc
role: STUDY_DIRECTOR
affiliation: AstraZeneca Medical Department
name: Andreja Hasenohrl, DVM
role: STUDY_CHAIR
References: