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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00999895
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 574

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CGI-CB scale score of subjects achieving a score of < 4.	At Week 18 - once

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇷 Serres, Greece