Clinical trial NCT00999895: A Study Evaluating the Treatment Selection and Outcome When Changing Antipsychotic Treatment in Schizophrenic Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Switch of antipsychotic treatment
Outcome evaluation
monotherapy
Greece
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-22
Enrollment: 574
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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).


Eligibility 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

Primary outcomes:
measure: CGI-CB scale score of subjects achieving a score of < 4.
timeFrame: At Week 18 - once
Secondary outcomes:
measure: Change in PANSS scale
timeFrame: 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
measure: Change in BARS scale
timeFrame: 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
measure: Changes in CGI-S and CGI-I scales
timeFrame: 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
Other outcomes:
Locations:
city: Patra
country: Greece
facility: Research Site
state: Achaias
city: Nafplio
country: Greece
facility: Research Site
state: Argolidas
city: Tripoli
country: Greece
facility: Research Site
state: Arkadias
city: Athens
country: Greece
facility: Research Site
state: Attikis
city: Koropi
country: Greece
facility: Research Site
state: Attikis
city: Neo Irakleio
country: Greece
facility: Research Site
state: Attikis
city: Athens
country: Greece
facility: Research Site
state: Attiki
city: Dafni
country: Greece
facility: Research Site
state: Attiki
city: Drapetsona
country: Greece
facility: Research Site
state: Attiki
city: Exarchia
country: Greece
facility: Research Site
state: Attiki
city: Glifada
country: Greece
facility: Research Site
state: Attiki
city: Ilioupoli
country: Greece
facility: Research Site
state: Attiki
city: Ilissia
country: Greece
facility: Research Site
state: Attiki
city: Koridalos
country: Greece
facility: Research Site
state: Attiki
city: Maroussi
country: Greece
facility: Research Site
state: Attiki
city: N. Makri
country: Greece
facility: Research Site
state: Attiki
city: P. Faliro
country: Greece
facility: Research Site
state: Attiki
city: Pagrati
country: Greece
facility: Research Site
state: Attiki
city: Peristeri
country: Greece
facility: Research Site
state: Attiki
city: Petroupoli
country: Greece
facility: Research Site
state: Attiki
city: Piraeus
country: Greece
facility: Research Site
state: Attiki
city: Zografou
country: Greece
facility: Research Site
state: Attiki
city: Chania
country: Greece
facility: Research Site
state: Chanion
city: Kos
country: Greece
facility: Research Site
state: Dodekanissou
city: Corfu
country: Greece
facility: Research Site
state: Eptanisa
city: Agrinio
country: Greece
facility: Research Site
state: Etoloakarnanias
city: Alexandroupoli
country: Greece
facility: Research Site
state: Evrou
city: Lamia
country: Greece
facility: Research Site
state: Fthiotidos
city: Heraklio
country: Greece
facility: Research Site
state: Herakliou
city: Veroia
country: Greece
facility: Research Site
state: Imatheias
city: Ioannina
country: Greece
facility: Research Site
state: Ioanninon
city: Karditsa
country: Greece
facility: Research Site
state: Karditsas
city: Kavala
country: Greece
facility: Research Site
state: Kavalas
city: Larissa
country: Greece
facility: Research Site
state: Larissas
city: Volos
country: Greece
facility: Research Site
state: Magnisias
city: Kalamata
country: Greece
facility: Research Site
state: Mesinias
city: Giannitsa
country: Greece
facility: Research Site
state: Pellas
city: Rethimno
country: Greece
facility: Research Site
state: Rethimnou
city: Komotini
country: Greece
facility: Research Site
state: Rodopis
city: Thessaloniki
country: Greece
facility: Research Site
state: Thessalonikis
city: Trikala
country: Greece
facility: Research Site
state: Trikalon
city: Thiva
country: Greece
facility: Research Site
state: Viotias
city: Serres
country: Greece
facility: Research Site
Study officials:
affiliation: Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
name: Panagiotis Pontikis, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.