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

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ClinicalTrials.gov Identifier: NCT02712463
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

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.

Condition or disease
Schizophrenia

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.

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Study Type : Observational
Actual Enrollment : 310 participants
Time Perspective: Retrospective
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 Start Date : July 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712463


Locations
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Brazil
Aracaju, Brazil
Brasilia, Brazil
Rio De Janeiro, Brazil
Sao Jose, Brazil
Sao Paulo, Brazil
Mexico
Durango, Mexico
Hermosillo, Mexico
Ixtapaluca, Mexico
Mexico, Mexico
Monterrey, Mexico
San Pedro Garza García, Mexico
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
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Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.

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Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT02712463     History of Changes
Other Study ID Numbers: CR107059
R092670SCH4039 ( Other Identifier: Janssen-Cilag Ltd. )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Keywords provided by Janssen-Cilag Ltd.:
Schizophrenia
Oral antipsychotics
Long acting Injectable antipsychotics
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs