Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00921362

Enrollment

1387

Registered

2009-06-16

Start date

2006-05-31

Completion date

2007-01-31

Last updated

2009-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Brief Psychiatric Rating Scale - BPRS	Monthly at every clinic visit- 7 times

Secondary

Measure	Time frame
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

Outcome results