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Completed

NCT Number: NCT00922090

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: CLIMAX

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 17, 2009
Registry last updated
Mar 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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