Observational study to assess data from the past related to the rate of hospitalization inPatients with Schizophrenia treated one year before with oral drugs for Schizophrenia andone year after with injectable drugs for Schizophrenia
- Conditions
- SchizophrenicF03.700
- Registration Number
- RBR-2x86dc
- Lead Sponsor
- niversidade Federal de São Paulo - UNIFESP/EPM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary outcome is the hospitalization rates associated with psychotic relapse and will be verified through the medical records revision.<br>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.<br>McNemar’s test will be performed for the analysis of the rate of hospitalization<br>associated with psychotic relapse in pre and post LAI periods in this 1-year mirror-image<br>study.
- Secondary Outcome Measures
Name Time Method The Secondary outcomes are the number of hospitalizations associated with psychotic relapse; days of hospitalization associated with psychotic relapse.<br>The comparison of the secondary outcomes between the pre-LAI and the LAI period will be done for the patients.<br>The following tests will be performed for comparing the pre and post LAI period among<br>patients in this 1-year mirror-image study: Wilcoxon signed rank test will be performed to compare differences in the<br>numbers of hospitalizations due to psychotic relapses; paired T-test will be performed to compare differences in the days of<br>hospitalizations related with psychotic relapses.<br>The level of statistical significance will be set at p<0.05, with confidence intervals of<br>95%.