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Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: June 15, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale - BPRS [ Time Frame: Monthly at every clinic visit- 7 times ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Severity of Illness [ Time Frame: Monthly/ at every clinic visit-7 times ] [ Designated as safety issue: No ]
  • CGI-S Clinical Global Impression Improvement CGI -I [ Time Frame: Monthly/ at every clinic visit except first visit- 6 times ] [ Designated as safety issue: No ]

Enrollment: 1387
Study Start Date: May 2006
Study Completion Date: January 2007
Schizophrenia patients under Seroquel treatment


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients eligible for entry into the study will have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature


Inclusion Criteria:

  • To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale
  • To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool

Exclusion Criteria:

  • All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00921362

Sponsors and Collaborators
Study Director: stina Pentiuc, Med Director AstraZeneca Romania
  More Information

No publications provided Identifier: NCT00921362     History of Changes
Other Study ID Numbers: NIS-NRO-SER-2006/2, SER-01-S-06
Study First Received: June 15, 2009
Last Updated: June 15, 2009
Health Authority: Romania: National Medicines Agency

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2014