Schizophrenia
Conditions
Keywords
Schizophrenia, Switch of antipsychotic treatment, Outcome evaluation, monotherapy, Greece
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).
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CGI-CB scale score of subjects achieving a score of < 4. | At Week 18 - once |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Greece
Outcome results
None listed