Observational study to assess data from the past related to the rate of hospitalization in Patients with Schizophrenia treated one year before with oral drugs for Schizophrenia and one year after with injectable drugs for Schizophrenia

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-2x86dc
• Date of registration: 15/04/2016
• Prospective Registration: No
• Primary sponsor: Universidade Federal de São Paulo - UNIFESP/EPM
• Public title: Observational study to assess data from the past related to the rate of hospitalization in Patients with Schizophrenia treated one year before with oral drugs for Schizophrenia and one year after with injectable drugs for Schizophrenia
• Scientific title: A retrospective, observational study to assess the rate of hospitalization in patients with Schizophrenia treated one year before with oral Antipsychotics and one year after with long acting injectable Atypical Atipsychotics - REALAI
• Date of first enrolment: 04/08/2015
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-2x86dc
• Study type: Observational
• Study design: Analitics observational retrospective study in database
• Phase: N/A

Countries of recruitment

Brazil, Mexico

Contacts

• Name: Vinicius Righi
• Affiliation: Janssen-Cilag Farmacêutica Ltda

• Name: Aline Medeiros da Silva
• Affiliation: Janssen-Cilag Farmacêutica Ltda

Key inclusion & exclusion 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: 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.

Age minimum: 18Y
Age maximum: 55Y
Gender: -

Health Condition(s) or Problem(s) studied

F03.700

Schizophrenic

Intervention(s)

Other

V02.300

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 and female schizophrenic subjects of age 18 to 55 years will be included in the study from different countries in Latinoamerica who were shifted to LAIs because of any of the following reasons: patient did not respond to oral antipsychotic treatment, patient’s choice, lack of adherence to oral treatment will be included in the study and will constitute the Study Population. The study will aim to enroll approximately 312 patients into the study.
Will be evaluated the number of hospitalizations associated with psychotic relapse one year before and one year after being treated with LAI anti-psychotics in schizophrenic patients as registered in the clinical reports. All subject data for this study are being collected using databases only. Will be collected: demographic information; co-morbidities during evaluation period; treatment history; use of hospital resources; treatment adherence.

Primary Outcome(s)

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 Outcome(s)

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%.

Source(s) of Monetary Support

Janssen-Cilag Farmacêutica Ltda

Secondary Sponsor(s)

Janssen-Cilag Farmacêutica Ltda