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

AstraZeneca1 site in 1 country574 target enrollmentOctober 2009

ConditionsSchizophrenia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: AstraZeneca
Enrollment: 574
Locations: 1
Primary Endpoint: CGI-CB scale score of subjects achieving a score of < 4.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

September 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

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

Outcomes

Primary Outcomes

CGI-CB scale score of subjects achieving a score of < 4.

Time Frame: At Week 18 - once

Secondary Outcomes

Change in PANSS scale(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(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(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)