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A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended (CLIMAX)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00922090
First received: June 12, 2009
Last updated: March 11, 2010
Last verified: March 2010
History of Changes

June 12, 2009
March 11, 2010
July 2009
January 2010   (final data collection date for primary outcome measure)
Change from baseline of the Clinical Global Impression score - Clinical Benefit Scale (CGI-CB) after 2 months of treatment with Seroquel XR [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00922090 on ClinicalTrials.gov Archive Site
  • CGI-I score's change from 7th day to 8weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended
A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended-Release Tablets (SEROQUEL XRâ) in Subjects With Schizophrenia-An Observational, Multicentric Prospective Study

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult diagnosed as Schizophrenia according to DSM-IV-TR criteria, the groups will be selected selected from general hospital or mental hospital.
Schizophrenia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1494
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00922090
NIS-NKR-SER-2009/1
No
MC MD, AstraZeneca Korea
AstraZeneca
Not Provided
Study Director: JoonWoo Bahn, MD, PhD AstraZeneca Korea
AstraZeneca
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP