SchizophreniaSELECTNCT00523783
Seroquel Long-Term NIS for Schizophrenia Patients
An observational study of Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 3 sites in South Korea.
Trial summary
To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- How many people
- 1,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- May 2007to May 2008
- 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
Who may be able to join
- The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
- The patient suffers from schizophrenia or schizoaffective disorder according to DSM-IV-TR
- The patient is between 18 and 65 years old(extremes included)
- On the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy
- If the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation
Who cannot join
- The patients who have known hypersensitivity to quetiapine
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Research Site
Seoul, Dongdamoon-gu
Research Site
Seoul, Kangnam-gu
Research Site
Seoul, Songpa-gu
About this study
Official title: 24-Week Naturalistic Observational Study of Efficacy of Quetiapine in Patients With Schizophrenia or Schizoaffective Disorder
To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective, quetiapine, long-term efficacy, Naturalistic, Observational
- Medical subject headings
- Schizophrenia, Psychotic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2007
- Study completionMay 2008
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
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joon-Woo Bahn, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523783
- Sponsor's protocol ID
- NIS-NKR-SER-2007/1
- Acronym
- SELECT
- Status last verified
- Aug 2007
- First submitted
- 29 Aug 2007
- Last updated
- 6 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-Week Naturalistic Observational Study of Efficacy of Quetiapine in Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00523783
- Acronym / sponsor ID
- SELECT / NIS-NKR-SER-2007/1
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective, quetiapine, long-term efficacy, Naturalistic, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 31 Aug 2007 (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.
To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
- The patient suffers from schizophrenia or schizoaffective disorder according to DSM-IV-TR
- The patient is between 18 and 65 years old(extremes included)
- On the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy
- If the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation
Key exclusion criteria (1 listed)
- The patients who have known hypersensitivity to quetiapine
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
Not reported in the source record.
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 6 Oct 2008.
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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.
Joon-Woo Bahn study director
AstraZeneca Korea
3 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 and Schizoaffective Disorder, run by AstraZeneca at 3 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 5 inclusion and 1 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 6 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 6 Oct 2008.