A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00922090
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective of this NIS is to assess the clinical benefit subjects derive from taking seroquel XR, using the CGI-CB. The secondary objective is to assess the effectiveness,safety and tolerability of seroquel XR tablets.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1494
Inclusion Criteria
- Diagnosed as Schizophrenia according to DSM-IV-TR criteria
- Patients who are taking Seroquel XR no longer than 1 month
- Patients who get antipsychotics monotherapy at least 1 week before enroll in this study
Exclusion Criteria
- First episode, drug naive schizophrenic subjects.
- Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis,concomitant organic mental disorder or mental retardation that in the opinion of the Principal Investigator may interfere with study conduct or interpretation.
- Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline of the Clinical Global Impression score - Clinical Benefit Scale (CGI-CB) after 2 months of treatment with Seroquel XR 8 weeks
- Secondary Outcome Measures
Name Time Method CGI-I score's change from 7th day to 8weeks 8 weeks Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks 8 weeks
Trial Locations
- Locations (1)
Research Site
🇰🇷Seoul, Korea, Republic of