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

NCT ID: NCT00922090

Last Updated: 2010-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Korea

Principal Investigators

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JoonWoo Bahn, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

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Research Site

Busan, , South Korea

Site Status

Research Site

Daegu, , South Korea

Site Status

Research Site

Goyang, , South Korea

Site Status

Research Site

Gwangju, , South Korea

Site Status

Research Site

Incheon, , South Korea

Site Status

Research Site

Jeju City, , South Korea

Site Status

Research Site

Kyung Gi, , South Korea

Site Status

Research Site

Kyungju, , South Korea

Site Status

Research Site

Kyungnam, , South Korea

Site Status

Research Site

Namyangju, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NIS-NKR-SER-2009/1

Identifier Type: -

Identifier Source: org_study_id

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