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A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients (ETOS)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 20, 2009
Last updated: January 31, 2011
Last verified: January 2011
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 Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • CGI-CB scale score of subjects achieving a score of < 4. [ Time Frame: At Week 18 - once ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 574
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Antipsychotic outpatients with schizophrenia
Switched treatment of antipsychotic outpatients with schizophrenia


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who have undergone a switch in their antipsychotic treatment and fulfill the following criteria will participate in the study.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00999895

Research Site
Patra, Achaias, Greece
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Nafplio, Argolidas, Greece
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Tripoli, Arkadias, Greece
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Athens, Attikis, Greece
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Koropi, Attikis, Greece
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Neo Irakleio, Attikis, Greece
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Athens, Attiki, Greece
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Dafni, Attiki, Greece
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Drapetsona, Attiki, Greece
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Exarchia, Attiki, Greece
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Glifada, Attiki, Greece
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Ilioupoli, Attiki, Greece
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Ilissia, Attiki, Greece
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Koridalos, Attiki, Greece
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Maroussi, Attiki, Greece
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N. Makri, Attiki, Greece
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P. Faliro, Attiki, Greece
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Pagrati, Attiki, Greece
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Peristeri, Attiki, Greece
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Petroupoli, Attiki, Greece
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Piraeus, Attiki, Greece
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Zografou, Attiki, Greece
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Chania, Chanion, Greece
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Kos, Dodekanissou, Greece
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Corfu, Eptanisa, Greece
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Agrinio, Etoloakarnanias, Greece
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Alexandroupoli, Evrou, Greece
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Lamia, Fthiotidos, Greece
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Heraklio, Herakliou, Greece
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Veroia, Imatheias, Greece
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Ioannina, Ioanninon, Greece
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Karditsa, Karditsas, Greece
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Kavala, Kavalas, Greece
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Larissa, Larissas, Greece
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Volos, Magnisias, Greece
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Kalamata, Mesinias, Greece
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Giannitsa, Pellas, Greece
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Rethimno, Rethimnou, Greece
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Komotini, Rodopis, Greece
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Thessaloniki, Thessalonikis, Greece
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Trikala, Trikalon, Greece
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Thiva, Viotias, Greece
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Serres, Greece
Sponsors and Collaborators
Study Director: Panagiotis Pontikis, Dr. Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: MC MD, AstraZeneca Identifier: NCT00999895     History of Changes
Other Study ID Numbers: NIS-NGR-DUM-2009/1
Study First Received: October 20, 2009
Last Updated: January 31, 2011

Keywords provided by AstraZeneca:
Switch of antipsychotic treatment
Outcome evaluation

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 20, 2017