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

January 31, 2011 updated by: AstraZeneca

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

574

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Serres, Greece
        • Research Site
    • Achaias
      • Patra, Achaias, Greece
        • Research Site
    • Argolidas
      • Nafplio, Argolidas, Greece
        • Research Site
    • Arkadias
      • Tripoli, Arkadias, Greece
        • Research Site
    • Attiki
      • 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
    • Attikis
      • Athens, Attikis, Greece
        • Research Site
      • Koropi, Attikis, Greece
        • Research Site
      • Neo Irakleio, Attikis, Greece
        • Research Site
    • Chanion
      • Chania, Chanion, Greece
        • Research Site
    • Dodekanissou
      • Kos, Dodekanissou, Greece
        • Research Site
    • Eptanisa
      • Corfu, Eptanisa, Greece
        • Research Site
    • Etoloakarnanias
      • Agrinio, Etoloakarnanias, Greece
        • Research Site
    • Evrou
      • Alexandroupoli, Evrou, Greece
        • Research Site
    • Fthiotidos
      • Lamia, Fthiotidos, Greece
        • Research Site
    • Herakliou
      • Heraklio, Herakliou, Greece
        • Research Site
    • Imatheias
      • Veroia, Imatheias, Greece
        • Research Site
    • Ioanninon
      • Ioannina, Ioanninon, Greece
        • Research Site
    • Karditsas
      • Karditsa, Karditsas, Greece
        • Research Site
    • Kavalas
      • Kavala, Kavalas, Greece
        • Research Site
    • Larissas
      • Larissa, Larissas, Greece
        • Research Site
    • Magnisias
      • Volos, Magnisias, Greece
        • Research Site
    • Mesinias
      • Kalamata, Mesinias, Greece
        • Research Site
    • Pellas
      • Giannitsa, Pellas, Greece
        • Research Site
    • Rethimnou
      • Rethimno, Rethimnou, Greece
        • Research Site
    • Rodopis
      • Komotini, Rodopis, Greece
        • Research Site
    • Thessalonikis
      • Thessaloniki, Thessalonikis, Greece
        • Research Site
    • Trikalon
      • Trikala, Trikalon, Greece
        • Research Site
    • Viotias
      • Thiva, Viotias, Greece
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Antipsychotic outpatients with schizophrenia
Switched treatment of antipsychotic outpatients with schizophrenia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CGI-CB scale score of subjects achieving a score of < 4.
Time Frame: At Week 18 - once
At Week 18 - once

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Panagiotis Pontikis, Dr., Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Estimate)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NGR-DUM-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe