A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended
CLIMAX
1 other identifier
observational
1,494
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Shorter than P25 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMarch 12, 2010
March 1, 2010
6 months
June 12, 2009
March 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Eligibility Criteria
Adult diagnosed as Schizophrenia according to DSM-IV-TR criteria, the groups will be selected selected from general hospital or mental hospital.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (11)
Research Site
Busan, South Korea
Research Site
Daegu, South Korea
Research Site
Goyang, South Korea
Research Site
Gwangju, South Korea
Research Site
Incheon, South Korea
Research Site
Jeju City, South Korea
Research Site
Kyung Gi, South Korea
Research Site
Kyungju, South Korea
Research Site
Kyungnam, South Korea
Research Site
Namyangju, South Korea
Research Site
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
JoonWoo Bahn, MD, PhD
AstraZeneca Korea
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 17, 2009
Study Start
July 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
March 12, 2010
Record last verified: 2010-03