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

NCT ID: NCT02712463

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with Schizophrenia

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.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.

Locations

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Aracaju, , Brazil

Site Status

Brasília, , Brazil

Site Status

Rio de Janeiro, , Brazil

Site Status

São José, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Durango, , Mexico

Site Status

Hermosillo, , Mexico

Site Status

Ixtapaluca, , Mexico

Site Status

México, , Mexico

Site Status

Monterrey, , Mexico

Site Status

San Pedro Garza García, , Mexico

Site Status

Countries

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Brazil Mexico

Other Identifiers

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R092670SCH4039

Identifier Type: OTHER

Identifier Source: secondary_id

CR107059

Identifier Type: -

Identifier Source: org_study_id

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