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

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ClinicalTrials.gov Identifier: NCT00922090
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : March 12, 2010
Sponsor:
Information provided by:
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.

Condition or disease
Schizophrenia

Study Type : Observational
Actual Enrollment : 1494 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. CGI-I score's change from 7th day to 8weeks [ Time Frame: 8 weeks ]
  2. Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MC MD, AstraZeneca Korea
ClinicalTrials.gov Identifier: NCT00922090     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2009/1
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: March 12, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs