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

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 Antipsychotics - REALAI Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02712463

Acronym

REALAI

Enrollment

310

Registered

2016-03-18

Start date

2015-07-31

Completion date

2016-04-30

Last updated

2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Oral antipsychotics, Long acting Injectable antipsychotics

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.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

Brazil, Mexico

Outcome results