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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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00981123
First received: September 14, 2009
Last updated: January 7, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure therapeutic response in schizophrenic patients using BPRS scale [ Time Frame: BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy) ] [ Designated as safety issue: No ]
  • To evaluate compliance with the prescribed antipsychotic treatment [ Time Frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate frequency of mental illnesses in patient's family [ Time Frame: at visit 1 (day 0) ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients or hospitalised patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981123

Locations
Croatia
Research Site
Bjelovar, Croatia
Research Site
Cakovec, Croatia
Research Site
Dubrovnik, Croatia
Research Site
Karlovac, Croatia
Research Site
Osijek, Croatia
Research Site
Popovaca, Croatia
Research Site
Pula, Croatia
Research Site
Rijeka, Croatia
Research Site
Sibenik, Croatia
Research Site
Sisak, Croatia
Research Site
Slavonski brod, Croatia
Research Site
Split, Croatia
Research Site
Varazdin, Croatia
Research Site
Vinkovci, Croatia
Research Site
Vukovar, Croatia
Research Site
Zabok, Croatia
Research Site
Zadar, Croatia
Research Site
Zagreb, Croatia
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ana Marija Gjurovic, MD , MSc AstraZeneca Medical Department
Study Chair: Andreja Hasenohrl, DVM AstraZeneca Medical Department
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00981123     History of Changes
Other Study ID Numbers: NIS-NHR-SER-2009/1
Study First Received: September 14, 2009
Last Updated: January 7, 2011
Health Authority: Croatia: Ethics Committee

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013