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Completed

NCT Number: NCT02712463

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aracaju, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

    Time frame: 12 months before initial LAI use

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

  2. 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

  1. Number of hospitalizations due to Psychotic Relapse of Schizophrenia

    Time frame: approximately 2 years

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

  2. Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia

    Time frame: approximately 2 years

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

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.

Industry

Registry information

Official study title

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

Acronym: REALAI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2016
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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