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Completed

NCT Number: NCT00999895

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

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).

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Pátrai, Achaias, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: At Week 18 - once

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ETOS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2009
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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