Clinical trial NCT02712463: A Study to Assess the Rate of Hospitalization in Participants With Schizophrenia Treated With Antipsychotics
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Oral antipsychotics
Long acting Injectable antipsychotics
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants (both gender and 18 to 55 years of age) with schizophrenia treated with oral anti-psychotics then switched to long acting Injectable anti-psychotics.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use
timeFrame: 12 months before initial LAI use
measure: Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use
timeFrame: 12 months after initial LAI use
Secondary outcomes:
measure: Number of hospitalizations due to Psychotic Relapse of Schizophrenia
timeFrame: approximately 2 years
measure: Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Aracaju
country: Brazil
city: Brasilia
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Sao Jose
country: Brazil
city: Sao Paulo
country: Brazil
city: Durango
country: Mexico
city: Hermosillo
country: Mexico
city: Ixtapaluca
country: Mexico
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
city: San Pedro Garza García
country: Mexico
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: