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

Janssen-Cilag Ltd.310 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

310

Conditions

Schizophrenia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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).

Locations (11)

Unnamed facility

Aracaju, Brazil

Unnamed facility

Brasília, Brazil

Unnamed facility

Rio de Janeiro, Brazil

Unnamed facility

São José, Brazil

Outcomes

Primary Outcomes

Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use

Percentage of participants with hospitalizations due to Psychotic relapse of schizophrenia will be reported.

Time frame: 12 months before initial LAI use

Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use

Time frame: 12 months after initial LAI use

Secondary Outcomes

Number of hospitalizations due to Psychotic Relapse of Schizophrenia

The number of hospitalizations due to Psychotic relapse of schizophrenia will be reported.

Time frame: approximately 2 years

Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia

The number of days of hospitalization due to Psychotic relapse of schizophrenia will be reported.

Time frame: approximately 2 years

Data from ClinicalTrials.gov

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