NCT02712463

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
• Phase: —
• Study type: Observational
• Enrollment: 310 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-03-18
• Last updated: 2016-05-24

Locations

11 sites across 2 countries: Brazil, Mexico