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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00999895
First received: October 20, 2009
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

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).


Condition
Schizophrenia

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
Antipsychotic outpatients with schizophrenia
Switched treatment of antipsychotic outpatients with schizophrenia

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT00999895

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

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov 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
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Schizophrenia
Switch of antipsychotic treatment
Outcome evaluation
monotherapy
Greece

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014