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Clinical Trials/NCT00921362
NCT00921362CompletedNot Applicable

Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

AstraZeneca0 sites1,387 target enrollmentStarted: May 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,387
Primary Endpoint
Brief Psychiatric Rating Scale - BPRS

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Brief Psychiatric Rating Scale - BPRS

Time Frame: Monthly at every clinic visit- 7 times

Secondary Outcomes

  • Clinical Global Impression Severity of Illness(Monthly/ at every clinic visit-7 times)
  • CGI-S Clinical Global Impression Improvement CGI -I(Monthly/ at every clinic visit except first visit- 6 times)

Investigators

Sponsor Class
Industry

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