Schizophrenic
Conditions
Interventions
This is a non-interventional study, i.e., will not be performed any interventional treatments or procedures. Will be only collected information from source data or a retrospective database.
Adult male
co-morbidities during evaluation period
treatment history
use of hospital resources
treatment adherence.
Other
Sponsors
Universidade Federal de São Paulo - UNIFESP/EPM
Janssen-Cilag Farmacêutica Ltda
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Out-Patients with the main diagnosis of schizophrenia; only clinical records with complete information during the 2 years period selected for data analysis will be included; patients treated with oral antipsychotics then switched to long acting injectable atypical due to poor adherence, lack of efficacy (no significant symptom reduction, judged by physician, at maximum recommended dose of an antipsychotic for 6 weeks), patients’ choice, when the switch has not been clearly justified or the switch has not been done during hospitalization; being regularly treated with long acting injectable atypical antipsychotics for at least 1 year after the initial use of long acting injectable atypical antipsychotics.
Exclusion criteria
Exclusion criteria: Patients that started long acting injectable atypical antipsychotics treatment as in-patients and patients that switched to long acting injectable atypical antipsychotics during hospitalization; patients with schizophrenia resistant to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary outcome is the hospitalization rates associated with psychotic relapse and will be verified through the medical records revision. The primary outcome will be compared in the patients before the long acting injectable atypical antipsychotics (LAI) use - pre-LAI period- and in the 12 months of LAI atypical antipsychotics use - LAI period. McNemar’s test will be performed for the analysis of the rate of hospitalization associated with psychotic relapse in pre and post LAI periods in this 1-year mirror-image study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary outcomes are the number of hospitalizations associated with psychotic relapse; days of hospitalization associated with psychotic relapse. The comparison of the secondary outcomes between the pre-LAI and the LAI period will be done for the patients. The following tests will be performed for comparing the pre and post LAI period among patients in this 1-year mirror-image study: Wilcoxon signed rank test will be performed to compare differences in the numbers of hospitalizations due to psychotic relapses; paired T-test will be performed to compare differences in the days of hospitalizations related with psychotic relapses. The level of statistical significance will be set at p<0.05, with confidence intervals of 95%. | — |
Countries
Brazil, Mexico
Contacts
Public ContactAline ;Vinicius da Silva;Righi
Janssen-Cilag Farmacêutica Ltda;Janssen-Cilag Farmacêutica Ltda
Outcome results
None listed