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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:
ClinicalTrials.gov Identifier:
NCT00981123
First Posted: September 22, 2009
Last Update Posted: January 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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:


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) ]

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) ]
  • To evaluate compliance with the prescribed antipsychotic treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy ]
  • 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 ]
  • To evaluate frequency of mental illnesses in patient's family [ Time Frame: at visit 1 (day 0) ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00981123     History of Changes
Other Study ID Numbers: NIS-NHR-SER-2009/1
First Submitted: September 14, 2009
First Posted: September 22, 2009
Last Update Posted: January 10, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs