NCT00921362CompletedNot Applicable
Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- 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
Similar Trials
Completed
Phase 2
Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg StudyObsessive Compulsive DisorderNCT00318539AstraZeneca90
Terminated
Phase 3
Seroquel XR in Adults With SchizophreniaSchizophreniaNCT00852631AstraZeneca28
Completed
Not Applicable
Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel DisorderFunctional Bowel DisordersNCT00617396University of North Carolina, Chapel Hill25
Completed
Phase 3
Quetiapine Treatment for Symptoms Associated With Borderline Personality DisorderBorderline Personality DisorderNCT00122070University of Medicine and Dentistry of New Jersey15
Completed
Phase 4
Seroquel Therapy for Substance Use Disorders Comorbid With SchizophreniaSubstance AbuseSubstance DependenceSchizophreniaSchizoaffective DisorderNCT00208143Creighton University20