SchizophreniaQTP NISNCT00809731
Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment
An observational study of Schizophrenia, run by AstraZeneca at 17 sites in Taiwan.
Trial summary
The objective of this study is to evaluate under routine clinical setting the efficacy and remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute episode or not achieving remission under regular treatment from schizophrenia/schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 490 participants
- Where
- 17 sitesTaiwan
- Study dates
- Dec 2008to Sep 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: Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)
Who may be able to join
- Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)
- Male or female aged between 18 and 65 years
- Patients recruited from both in-patient and out-patient clinics
- Patients who are cooperative, by judgment from investigators, and the use of oral antipsychotic considered adequate
Who cannot join
- Pregnancy or lactation
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance, lack of response, or contraindication to prescribed atypical antipsychotic, as judged by the investigator
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment and patients prescribed with clozapine within 3 months prior to enrolment
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Taiwan17 sites
Research Site
Changhua
Research Site
Changhua-Lugang
Research Site
Chiayi City
Research Site
Kaohsiung-Niosong
Research Site
Kaohsiung-Sanmin
Research Site
Kaohsiung-Yanchao
Research Site
Keelung
Research Site
Miaoli
Research Site
Miaoli-Toufen
Research Site
Taichung-Beitun
Research Site
Taichung-Shalu
Research Site
Taipei-Banciao
Research Site
Taipei-Datong
Research Site
Taipei-Shilin
Research Site
Taipei-Shipai
Research Site
Taipei-Xindian
Research Site
Taoyuan
About this study
Official title: A Naturalistic Observational Study to Evaluate Efficacy of 2nd-generation Antipsychotics and Remission Status for Patients With Schizophrenia / Schizoaffective Disorder
The objective of this study is to evaluate under routine clinical setting the efficacy and remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute episode or not achieving remission under regular treatment from schizophrenia/schizoaffective disorder. This study will collect in real-life practice the severity of schizophrenia by Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group, the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by documenting spontaneous reports on adverse events as well as change in body weight.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia remission status by 8-item PANSS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | All commercially available 2nd-generation antipsychotic with an indication of treating schizophrenia will be prescribed by the physician according to normal practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-Severity of illness (CGI-SI)
Measured: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
Secondary outcomes (3)
CGI-Degree of change (CGI-DC)
Measured: Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
MADRS, GAF, DIEPSS
Measured: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
Remission status
Measured: Visit 1(Day 0), 5(Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2010
- Study completionSep 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
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yuan-Hwa Chou, MD, PhD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809731
- Sponsor's protocol ID
- NIS-NTW-SER-2008/1
- Acronym
- QTP NIS
- Status last verified
- Dec 2010
- First submitted
- 15 Dec 2008
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Observational Study to Evaluate Efficacy of 2nd-generation Antipsychotics and Remission Status for Patients With Schizophrenia / Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00809731
- Acronym / sponsor ID
- QTP NIS / NIS-NTW-SER-2008/1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia remission status by 8-item PANSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Dec 2008 (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 objective of this study is to evaluate under routine clinical setting the efficacy and remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute episode or not achieving remission under regular treatment from schizophrenia/schizoaffective disorder. This study will collect in real-life practice the severity of schizophrenia by Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group, the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by documenting spontaneous reports on adverse events as well as change in body weight.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | –All commercially available 2nd-generation antipsychotic with an indication of treating schizophrenia will be prescribed by the physician according to normal practices |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)
Key inclusion criteria (4 listed)
- Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)
- Male or female aged between 18 and 65 years
- Patients recruited from both in-patient and out-patient clinics
- Patients who are cooperative, by judgment from investigators, and the use of oral antipsychotic considered adequate
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance, lack of response, or contraindication to prescribed atypical antipsychotic, as judged by the investigator
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment and patients prescribed with clozapine within 3 months prior to enrolment
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
CGI-Severity of illness (CGI-SI)
Time frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
3 secondary outcomes
CGI-Degree of change (CGI-DC)
Time frame: Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
MADRS, GAF, DIEPSS
Time frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
Remission status
Time frame: Visit 1(Day 0), 5(Week 4)
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 9 Dec 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.
Yuan-Hwa Chou, MD, PhD principal investigator
Taipei Veterans General Hospital, Taiwan
17 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 17 sites in Taiwan.
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 4 inclusion and 4 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 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Taiwan. 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?
CGI-Severity of illness (CGI-SI) (time frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)). 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 9 Dec 2010; AzTrials last refreshed its copy on 3 Nov 2026.