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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT02712463
• Lead Sponsor: Janssen-Cilag Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use	12 months before initial LAI use	Percentage of participants with hospitalizations due to Psychotic relapse of schizophrenia will be reported.
Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use	12 months after initial LAI use

Secondary Outcome Measures

Name	Time	Method
Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia	approximately 2 years	The number of days of hospitalization due to Psychotic relapse of schizophrenia will be reported.
Number of hospitalizations due to Psychotic Relapse of Schizophrenia	approximately 2 years	The number of hospitalizations due to Psychotic relapse of schizophrenia will be reported.