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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00922090

Acronym

CLIMAX

Enrollment

1494

Registered

2009-06-17

Start date

2009-07-31

Completion date

2010-01-31

Last updated

2010-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Seroquel XR, CGI-CB, SWN-K

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
CGI-I score's change from 7th day to 8weeks	8 weeks
Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks	8 weeks

Countries

South Korea

Outcome results