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

NCT ID: NCT00981123

Last Updated: 2011-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Ana Marija Gjurovic, MD, MSc

Role: STUDY_DIRECTOR

AstraZeneca Medical Department

Andreja Hasenohrl, DVM

Role: STUDY_CHAIR

AstraZeneca Medical Department

Locations

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Research Site

Bjelovar, , Croatia

Site Status

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Čakovec, , Croatia

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Dubrovnik, , Croatia

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Karlovac, , Croatia

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Osijek, , Croatia

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Popovača, , Croatia

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Pula, , Croatia

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Rijeka, , Croatia

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Sisak, , Croatia

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Slavonski Brod, , Croatia

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Split, , Croatia

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Šibenik, , Croatia

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Varaždin, , Croatia

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Vinkovci, , Croatia

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Vukovar, , Croatia

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Zabok, , Croatia

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Zadar, , Croatia

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Zagreb, , Croatia

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Countries

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Croatia

Other Identifiers

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NIS-NHR-SER-2009/1

Identifier Type: -

Identifier Source: org_study_id

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