SchizophreniaETOSNCT00999895
A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients
An observational study of Schizophrenia, run by AstraZeneca at 43 sites in Greece.
Trial summary
The purpose of the study is to evaluate the outcome of treatment switch defined as an improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 574 participants
- Where
- 43 sitesGreece
- Study dates
- Oct 2009to 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: Subjects who have undergone a switch in their antipsychotic treatment and fulfill the following criteria will participate in the study.
Who may be able to join
- Diagnosis of schizophrenia (as per DSM-IV), at least 6 months prior to enrolment in the study
- Subjects who have initiated a new antipsychotic treatment within the preceding 2 weeks
- Subjects whose prior and current antipsychotic treatment consists of any typical or atypical antipsychotic monotherapy
Who cannot join
- Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from schizophrenia), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
- Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria and not in full remission
- Female subjects who are pregnant or lactating
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Greece43 sites
Research Site
Agrinio, Etoloakarnanias
Research Site
Alexandroupoli, Evrou
Research Site
Athens, Attica
Research Site
Athens, Attikis
Research Site
Chania, Chanion
Research Site
Corfu, Eptanisa
Research Site
Dafni, Attica
Research Site
Drapetsona, Attica
Research Site
Exarcheia, Attica
Research Site
Giannitsá, Pellas
Research Site
Glifada, Attica
Research Site
Heraklio, Herakliou
Research Site
Ilioúpoli, Attica
Research Site
Ilissia, Attica
Research Site
Ioannina, Ioanninon
Research Site
Kalamata, Mesinias
Research Site
Karditsa, Karditsas
Research Site
Kavala, Kavalas
Research Site
Komotini, Rodopis
Research Site
Koridalos, Attica
Research Site
Koropí, Attikis
Research Site
Kos, Dodekanissou
Research Site
Lamia, Fthiotidos
Research Site
Larissa, Larissas
Research Site
Marousi, Attica
Research Site
N. Makri, Attica
Research Site
Nafplion, Argolidas
Research Site
Néo Irákleio, Attikis
Research Site
P. Faliro, Attica
Research Site
Pangrati, Attica
Research Site
Pátrai, Achaias
Research Site
Peristeri, Attica
Research Site
Petroúpolis, Attica
Research Site
Piraeus, Attica
Research Site
Rethymno, Rethimnou
Research Site
Serres, Serres
Research Site
Thebes, Viotias
Research Site
Thessaloniki, Thessalonikis
Research Site
Trikala, Trikalon
Research Site
Tripoli, Arkadias
Research Site
Véroia, Imatheias
Research Site
Volos, Magnisias
Research Site
Zografos, Attica
About this study
Official title: A Non-interventional, Prospective, Open-label Study for the Evaluation of the Selection and Outcome of the Antipsychotic Treatment Switch in Outpatients With Schizophrenia - ETOS Study
The purpose of the study is to evaluate the outcome of treatment switch defined as an improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Switch of antipsychotic treatment, Outcome evaluation, monotherapy, Greece
- 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 |
|---|---|---|
| Antipsychotic outpatients with schizophrenia | Switched treatment of antipsychotic outpatients with schizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-CB scale score of subjects achieving a score of < 4.
Measured: At Week 18 - once
Secondary outcomes (3)
Change in PANSS scale
Measured: Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks
Change in BARS scale
Measured: Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks
Changes in CGI-S and CGI-I scales
Measured: Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Panagiotis Pontikis, Dr., Study director, Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999895
- Sponsor's protocol ID
- NIS-NGR-DUM-2009/1
- Acronym
- ETOS
- Status last verified
- Jan 2011
- First submitted
- 20 Oct 2009
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Roussidis A, Kalkavoura C, Dimelis D, Theodorou A, Ioannidou I, Mellos E, Mylonaki T, Spyropoulou A, Yfantis A. Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study. Ann Gen Psychiatry. 2013 Dec 20;12(1):42. doi: 10.1186/1744-859X-12-42.
PubMed 24359635
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Prospective, Open-label Study for the Evaluation of the Selection and Outcome of the Antipsychotic Treatment Switch in Outpatients With Schizophrenia - ETOS Study
- ClinicalTrials.gov ID
- NCT00999895
- Acronym / sponsor ID
- ETOS / NIS-NGR-DUM-2009/1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Switch of antipsychotic treatment, Outcome evaluation, monotherapy, Greece
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Oct 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 evaluate the outcome of treatment switch defined as an improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic outpatients with schizophrenia | – | –Switched treatment of antipsychotic outpatients with schizophrenia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone a switch in their antipsychotic treatment and fulfill the following criteria will participate in the study.
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia (as per DSM-IV), at least 6 months prior to enrolment in the study
- Subjects who have initiated a new antipsychotic treatment within the preceding 2 weeks
- Subjects whose prior and current antipsychotic treatment consists of any typical or atypical antipsychotic monotherapy
Key exclusion criteria (3 listed)
- Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from schizophrenia), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
- Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria and not in full remission
- Female subjects who are pregnant or lactating
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-CB scale score of subjects achieving a score of < 4.
Time frame: At Week 18 - once
3 secondary outcomes
Change in PANSS scale
Time frame: Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks
Change in BARS scale
Time frame: Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks
Changes in CGI-S and CGI-I scales
Time frame: Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 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 1 Feb 2011.
- Derived from this study: PubMed 24359635Roussidis A, Kalkavoura C, Dimelis D, Theodorou A, Ioannidou I, Mellos E, Mylonaki T, Spyropoulou A, Yfantis A. Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study. Ann Gen Psychiatry. 2013 Dec 20;12(1):42. doi: 10.1186/1744-859X-12-42.
Related trials for Schizophrenia
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
Recruiting
tACS for Working Memory in Schizophrenia
Schizophrenia, Working Memory
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
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.
Panagiotis Pontikis, Dr. study director
Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
43 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 43 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 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 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
CGI-CB scale score of subjects achieving a score of < 4. (time frame: At Week 18 - once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999895, which also lists 1 linked publication.
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 1 Feb 2011.