A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients - Full Text View

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:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999895

Locations

Greece
Research Site
Patra, Achaias, Greece
Research Site
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
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
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013

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