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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00922090
Collaborator
(none)
1,494
Enrollment
11
Locations
6
Duration (Months)
135.8
Patients Per Site
22.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jul 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Jan 1, 2010

    Outcome Measures

    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 [8 weeks]

    Secondary Outcome Measures

    1. CGI-I score's change from 7th day to 8weeks [8 weeks]

    2. Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Busan Korea, Republic of
    2 Research Site Daegu Korea, Republic of
    3 Research Site Goyang Korea, Republic of
    4 Research Site Gwangju Korea, Republic of
    5 Research Site Incheon Korea, Republic of
    6 Research Site Jeju Korea, Republic of
    7 Research Site Kyung gi Korea, Republic of
    8 Research Site Kyungju Korea, Republic of
    9 Research Site Kyungnam Korea, Republic of
    10 Research Site Namyangju Korea, Republic of
    11 Research Site Seoul Korea, Republic of

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: JoonWoo Bahn, MD, PhD, AstraZeneca Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00922090
    Other Study ID Numbers:
    • NIS-NKR-SER-2009/1
    First Posted:
    Jun 17, 2009
    Last Update Posted:
    Mar 12, 2010
    Last Verified:
    Mar 1, 2010
    Keywords provided by , ,
    Schizophrenia
    Seroquel XR
    CGI-CB
    SWN-K
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Mar 12, 2010