A Study to Assess the Rate of Hospitalization in Participants With Schizophrenia Treated With Antipsychotics (REALAI)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Schizophrenia

Study type: Observational

Funder types: Industry

Identifiers

NCT02712463

R092670SCH4039 (Other Identifier)

CR107059

Details and patient eligibility

About

The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsychotics and one year after with long acting injectable atypical antipsychotics.

Full description

This is a retrospective (take a look back at events that already have taken place), observational, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adults with a diagnosis of Schizophrenia during the time period from 01 January 2009 through 31-December-2013 (only for Mexican population). Data will be collected from clinical practice. The medical records of participants will be screened and eligible participants data will be collected. The period of observation will span from 12 months before initial Long Acting Injectable (LAI) use and in 12 months after the initial LAIs use. The rate of hospitalization will be primarily evaluated.

Enrollment: 310 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Out-Patients with the main diagnosis of schizophrenia with Diagnostic and Statistical Manual of Mental Disorders (DSM-4 criteria)
• Only clinical records with complete information during the 2 years period selected for data analysis will be included
• Participants treated with oral antipsychotics then switched to Long Acting Injectable (LAI) due to poor adherence, lack of efficacy (no significant symptom reduction, judged by physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants choice, (Excluding for the Brazil population, when the switch has not been clearly justified or the switch has not been done during hospitalization)
• Being regularly treated with LAI atypical antipsychotics for at least 1 year after the initial use of LAI atypical antipsychotics

Exclusion criteria

• Participants with refractory schizophrenia (RS)
• Participants that started LAI treatment as in-patients and patients that switched to LAI during hospitalization (only for Mexican population).

Trial design

310 participants in 1 patient group

Participants with Schizophrenia

Description:

This is an observational study. Data will be collected from the medical records of participants diagnosed with schizophrenia and who had been on oral antipsychotics for at least one year and thereafter have been switched to Long Acting Injectable atypical antipsychotics for at least one year.