Schizophrenia Clinical Trial
— REALAIOfficial 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
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.
Status | Completed |
Enrollment | 310 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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). |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag Ltd. |
Brazil, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use | Percentage of participants with hospitalizations due to Psychotic relapse of schizophrenia will be reported. | 12 months before initial LAI use | No |
Primary | Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use | 12 months after initial LAI use | No | |
Secondary | Number of hospitalizations due to Psychotic Relapse of Schizophrenia | The number of hospitalizations due to Psychotic relapse of schizophrenia will be reported. | approximately 2 years | No |
Secondary | Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia | The number of days of hospitalization due to Psychotic relapse of schizophrenia will be reported. | approximately 2 years | No |
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