SchizophreniaCLIMAXNCT00922090
A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended
An observational study of Schizophrenia, run by AstraZeneca at 11 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 1,494 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Jul 2009to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult diagnosed as Schizophrenia according to DSM-IV-TR criteria, the groups will be selected selected from general hospital or mental hospital.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Research Site
Busan
Research Site
Daegu
Research Site
Goyang
Research Site
Gwangju
Research Site
Incheon
Research Site
Jeju City
Research Site
Kyung Gi
Research Site
Kyungju
Research Site
Kyungnam
Research Site
Namyangju
Research Site
Seoul
About this study
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
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.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Seroquel XR, CGI-CB, SWN-K
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the Clinical Global Impression score - Clinical Benefit Scale (CGI-CB) after 2 months of treatment with Seroquel XR
Measured: 8 weeks
Secondary outcomes (2)
CGI-I score's change from 7th day to 8weeks
Measured: 8 weeks
Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- JoonWoo Bahn, MD, PhD, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922090
- Sponsor's protocol ID
- NIS-NKR-SER-2009/1
- Acronym
- CLIMAX
- Status last verified
- Mar 2010
- First submitted
- 12 Jun 2009
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00922090
- Acronym / sponsor ID
- CLIMAX / NIS-NKR-SER-2009/1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Seroquel XR, CGI-CB, SWN-K
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,494 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult diagnosed as Schizophrenia according to DSM-IV-TR criteria, the groups will be selected selected from general hospital or mental hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
CGI-I score's change from 7th day to 8weeks
Time frame: 8 weeks
Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JoonWoo Bahn, MD, PhD study director
AstraZeneca Korea
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by AstraZeneca at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2010.