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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
  Purpose

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.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1494
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult diagnosed as Schizophrenia according to DSM-IV-TR criteria, the groups will be selected selected from general hospital or mental hospital.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922090

Locations
Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Goyang, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Incheon, Korea, Republic of
Research Site
Jeju, Korea, Republic of
Research Site
Kyung gi, Korea, Republic of
Research Site
Kyungju, Korea, Republic of
Research Site
Kyungnam, Korea, Republic of
Research Site
Namyangju, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: JoonWoo Bahn, MD, PhD AstraZeneca Korea
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca Korea
ClinicalTrials.gov Identifier: NCT00922090     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2009/1
Study First Received: June 12, 2009
Last Updated: March 11, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Schizophrenia
Seroquel XR
CGI-CB
SWN-K

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014