SchizophreniaNCT00833456
NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 14 sites in Slovenia.
Trial summary
The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia
- How many people
- 106 participants
- Where
- 14 sitesSlovenia
- Study dates
- Feb 2009to Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients visiting psychiatrist's practice
Who may be able to join
- patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
- patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
- or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion
Who cannot join
- patients who are treated with Seroquel SR or other antipsychotic more than 1 month
- patients with prescribed antipsychotic combinations
- pregnant women or women who are breast-feeding
- patients who have been treated with antipsychotics in depot formulations for the last two months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Slovenia14 sites
Research Site
Begunje na Gorenjskem
Research Site
Brežice
Research Site
Brezovica pri Ljubljani
Research Site
Idrija
Research Site
Koper
Research Site
Ljubljana
Research Site
Maribor
Research Site
Nova Gorica
Research Site
Novo Mesto
Research Site
Ormoz
Research Site
Postojna
Research Site
Radenci
Research Site
Sežana
Research Site
Vojnik
About this study
Official title: Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics
The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, Seroquel SR, atypical antipsychotics, assessment of functioning, GAF scale
- 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 |
|---|---|---|
| 1 | Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion | |
| 2 | Atypical antipsychotics: Patients whose symptoms are controlled with atypical antipsychotic in once daily formulation (excluding Seroquel SR) and started with the therapy up to 1 month before the inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group.
Measured: three times: 0, 12 and 24 weeks after inclusion
Secondary outcomes (1)
To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics
Measured: three times: 0, 12 and 24 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionNov 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-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Pregelj, MD, PhD, Principal investigator, Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833456
- Sponsor's protocol ID
- NIS-NSI-SER-2008/1
- Status last verified
- Oct 2011
- First submitted
- 29 Jan 2009
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics
- ClinicalTrials.gov ID
- NCT00833456
- Acronym / sponsor ID
- NIS-NSI-SER-2008/1
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, Seroquel SR, atypical antipsychotics, assessment of functioning, GAF scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Feb 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 purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion |
| 2 | – | –Atypical antipsychotics: Patients whose symptoms are controlled with atypical antipsychotic in once daily formulation (excluding Seroquel SR) and started with the therapy up to 1 month before the inclusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients visiting psychiatrist's practice
Key inclusion criteria (3 listed)
- patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
- patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
- or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion
Key exclusion criteria (4 listed)
- patients who are treated with Seroquel SR or other antipsychotic more than 1 month
- patients with prescribed antipsychotic combinations
- pregnant women or women who are breast-feeding
- patients who have been treated with antipsychotics in depot formulations for the last two months
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
To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group.
Time frame: three times: 0, 12 and 24 weeks after inclusion
1 secondary outcome
To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics
Time frame: three times: 0, 12 and 24 weeks after inclusion
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 14 Oct 2011.
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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.
Peter Pregelj, MD, PhD principal investigator
Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana
14 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 14 sites in Slovenia.
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 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 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Slovenia. 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?
To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group. (time frame: three times: 0, 12 and 24 weeks after inclusion). 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 14 Oct 2011.