Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole in Spain (PROSIGO)

Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole Long-acting Injection in the Spanish Clinical Practice: a Retrospective, Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Spain
  • Alava, Spain
    • Hospital Universitario de Alava
  • Alcorcón, Spain
    • Hospital Fundación Alcorcón
  • Barcelona, Spain
    • Numància Salut Mental (Parc Sanitari St Joan de Deu)
  • Ciudad Real, Spain
    • Hospital de Ciudad Real
  • Girona, Spain
    • Hospital IAS Girona
  • L'Hospitalet de Llobregat, Spain
    • Hospital Universitari Bellvitge
  • Leon, Spain
    • Complejo Asistencial Universitario de León
  • Madrid, Spain
    • Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital Infanta Leonor
  • Madrid, Spain
    • Hgu Gregorio Maranon
  • Malaga, Spain
    • Hospital Carlos Haya
  • Sant Boi de Llobregat, Spain
    • Parc Sanitari St. Joan de Deu (St. Boi)
  • Santiago de Compostela, Spain
    • Hospital Santiago De Compostela
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocío
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Adult patients (age ≥ 18 years at the time of AOM initiation).
2. 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.
3. 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).

4. 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.

   • A reasonable effort is defined as 3 contact attempts separated by 3 weeks. All efforts to obtain the informed consent, reasonable or not, shall be registered in the medical history of the patient to be used as documental source.

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:

1. The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
2. Chronically hospitalized patients at time of AOM initiation.

3. 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.

4. Participation in an interventional clinical trial during the retrospective follow-up period.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Europe Ltd

Publications and helpful links

General Publications

• 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. Erratum In: Eur Psychiatry. 2021 Oct 11;64(1):e59.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: persistence; long-acting injectable antipsychotic
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 031-307-00162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No