SchizophreniaAURANCT00857064
Subjective Well Being of Schizophrenic Patients in Greece
An observational study of Schizophrenia, run by AstraZeneca at 24 sites in Greece.
Trial summary
Non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with Schizophrenia under antipsychotic medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 600 participants
- Where
- 24 sitesGreece
- Study dates
- Mar 2009to Oct 2009
- 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: Target Group:Patients suffering from Schizophrenia treated in private practice
Who may be able to join
- Provision of written informed consent
- Diagnosis of schizophrenia according to DSM-IV
- The patient must have been prescribed an atypical antipsychotic for at least 4 weeks before the first study visit
Who cannot join
- -
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Greece24 sites
Research Site
Agrinio
Research Site
Alexsandroupoli
Research Site
Argos
Research Site
Arta
Research Site
Athens
Research Site
Crete
Research Site
Drama
Research Site
Edessa
Research Site
Elefsina
Research Site
Giannitsá
Research Site
Ioannina
Research Site
Karditsa
Research Site
Katerini
Research Site
Kavala
Research Site
Kozani
Research Site
Larissa
Research Site
Pátrai
Research Site
Piraeus
Research Site
Preveza
Research Site
Rhodes
Research Site
Serres
Research Site
Thebes
Research Site
Thessaloniki
Research Site
Volos
About this study
Non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to the treatment and will investigate whether there is any correlation of these factors with the clinical condition of these patients.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, antipsychotics, social functioning, subjective well being, Patients suffering from Schizophrenia
- Medical subject headings
- Schizophrenia, Social Adjustment
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Subjective well being
Measured: Relative score reported in SWBN scale at the visit. No baseline comparison
Assessment of functioning
Measured: Relative score reported in GAF scale at the visit. No baseline comparison
Secondary outcomes (3)
Assessment of Compliance to therapy
Measured: Relative score reported in BARS scale at the visit. No baseline comparison
Assessment of General Psychopathology
Measured: Relative score reported in PANNS scale at the visit. No baseline comparison
Assessment of Clinical Condition
Measured: Relative score reported in CGIS scale at the visit. No baseline comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
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
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Errikos Tzempelikos, Dr, Principal investigator, Sismanoglio Hospital, Psychiatric Department, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857064
- Sponsor's protocol ID
- NIS-NGR-DUM-2008/2
- Acronym
- AURA
- Status last verified
- Dec 2010
- First submitted
- 3 Mar 2009
- 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
- Subjective Well Being of Schizophrenic Patients in Greece
- ClinicalTrials.gov ID
- NCT00857064
- Acronym / sponsor ID
- AURA / NIS-NGR-DUM-2008/2
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, antipsychotics, social functioning, subjective well being, Patients suffering from Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Mar 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.
Non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to the treatment and will investigate whether there is any correlation of these factors with the clinical condition of these patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target Group:Patients suffering from Schizophrenia treated in private practice
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Diagnosis of schizophrenia according to DSM-IV
- The patient must have been prescribed an atypical antipsychotic for at least 4 weeks before the first study visit
Key exclusion criteria (1 listed)
- -
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
Assessment of Subjective well being
Time frame: Relative score reported in SWBN scale at the visit. No baseline comparison
Assessment of functioning
Time frame: Relative score reported in GAF scale at the visit. No baseline comparison
3 secondary outcomes
Assessment of Compliance to therapy
Time frame: Relative score reported in BARS scale at the visit. No baseline comparison
Assessment of General Psychopathology
Time frame: Relative score reported in PANNS scale at the visit. No baseline comparison
Assessment of Clinical Condition
Time frame: Relative score reported in CGIS scale at the visit. No baseline comparison
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.
Errikos Tzempelikos, Dr principal investigator
Sismanoglio Hospital, Psychiatric Department, Greece
24 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 24 sites in Greece.
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 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 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 24 sites in Greece. 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?
Assessment of Subjective well being (time frame: Relative score reported in SWBN scale at the visit. No baseline comparison). The study lists 2 primary outcomes in all. 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.