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This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
Data from each patient will be collected after informed consent is obtained (if possible), and will include retrospective information mainly from the index date (start of AOM treatment, baseline timepoint) until the last information available in the patient file at the time of data collection (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once-monthly).
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| Measure | Description | Time Frame |
|---|---|---|
| Persistence (days) with aripiprazole once-monthly | To describe in real-world practice the impact of demographic and clinical characteristics on persistence in patients with schizophrenia initiated on aripiprazole once-monthly (AOM) during an inpatient stay due to an acute schizophrenia relapse. | First 6 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Description of reasons of treatment discontinuation (number of discontinuations per reason) | Date of AOM interruption or discontinuation and reason for discontinuation | From treatment initiation up to patient inclusion (minimum 6 months) |
| Change over time in Clinical Global Impressions - Severity (CGI-S) scale |
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Inclusion Criteria:
Adult patients (age ≥ 18 years at the time of AOM initiation).
Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders V available at start of AOM treatment, and confirmed by the current investigator.
Having been hospitalized for an acute psychotic relapse and having been initiated with AOM as primary maintenance antipsychotic treatment, in accordance with the terms of the marketing authorisation, during the hospitalisation, at least 6 months before the inclusion and before November 1st 2016 (and up to January 2016 at the earliest).
Provision of patient informed consent unless a) not required by local regulations, b) it would take a non-reasonable effort* or c) if the source patient is deceased or untraceable.
If allowable by Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.
Exclusion Criteria:
The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
Chronically hospitalized patients at time of AOM initiation.
Patients who receive, after AOM initiation, a concomitant oral antipsychotic treatment for more than 4 weeks (with the exception of low dose quetiapine)*
* Low dose quetiapine is acceptable up to a maximum of 150 mg daily only for sedative purposes, but not for the induction of any psychopharmacological effect on mood and/or psychosis.
Participation in an interventional clinical trial during the retrospective follow-up period.
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Eligible patients will include adult patients with schizophrenia who have been initiated with AOM as primary maintenance AP treatment during an inpatient stay due to an acute schizophrenia relapse in a real clinical practice setting at least 6 months before the inclusion in the study (regardless of the current treatment at inclusion). Since persistence is part of the primary objective of the study, patients who discontinued the maintenance treatment with AOM before the inclusion period of the study should also be included.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Department | Otsuka Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Álava | Alava | Spain | ||||
| Hospital Fundación Alcorcón |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33840396 | Derived | Olivares JM, Gonzalez-Pinto A, Paramo M; PROSIGO Study Group. Predictors of persistence in patients with schizophrenia treated with aripiprazole once-monthly long-acting injection in the Spanish clinical practice: a retrospective, observational study. Eur Psychiatry. 2021 Apr 12;64(1):e40. doi: 10.1192/j.eurpsy.2021.23. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Clinical Global Impressions - Severity (CGI-S) scale at index date (if available in patient's file or estimated by the investigator according to medical records) and CGI-S up to patient's inclusion (if available in patients' file or estimated by the investigator according to medical records). CGI-S up to patient's inclusion (if available in patients' file or estimated by the investigator according to medical records). |
| From treatment initiation up to patient inclusion (minimum 6 months) |
| Change over time in the Brief Psychiatric Rating Scale (BPRS) | Brief Psychiatric Rating Scale (BPRS) at index date (if available in patient's file) and BPRS up to the patient's inclusion (if available in patients' file). | From treatment initiation up to patient inclusion (minimum 6 months) |
| Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings) | Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings) | From treatment initiation up to patient inclusion (minimum 6 months) |
| Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures) | Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures) | From treatment initiation up to patient inclusion (minimum 6 months) |
| Description of non-pharmacological interventions aiming to improve functionality (types, numbers of patients per type) | Description of non-pharmacological interventions aiming to improve functionality (including, if applicable, initiation and end dates of Institutional support, Cognitive behavioural therapy (CBT), Assertive Community Treatment/Case management, Group or individual psychoeducation, Family psychoeducation, Group or individual psychotherapy, Structured rehabilitation program, Occupational support, Severe mental illness management program) | From treatment initiation up to patient inclusion (minimum 6 months) |
| Description of patterns of alcohol and drug abuse and/or dependence (patterns of drug abuse, type of substance, frequency of consumption) | To qualitatively describe patterns of drug abuse and/or dependence | From treatment initiation up to patient inclusion (minimum 6 months) |
| Alcorcón |
| Spain |
| Numància Salut Mental (Parc Sanitari St Joan de Deu) | Barcelona | Spain |
| Hospital de Ciudad Real | Ciudad Real | Spain |
| Hospital IAS Girona | Girona | Spain |
| Hospital Universitari Bellvitge | L'Hospitalet de Llobregat | Spain |
| Complejo Asistencial Universitario de Leon | León | Spain |
| Fundación Jiménez Díaz | Madrid | Spain |
| HGU Gregorio Marañón | Madrid | Spain |
| Hospital Infanta Leonor | Madrid | Spain |
| Hospital Carlos Haya | Málaga | Spain |
| Parc Sanitari St. Joan de Deu (St. Boi) | Sant Boi de Llobregat | Spain |
| Hospital Santiago de Compostela | Santiago de Compostela | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Spain |