Clinical trial NCT03130478: Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole in Spain
Official title: Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole Long-acting Injection in the Spanish Clinical Practice: a Retrospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: long-acting injectable antipsychotic
persistence
Lead sponsor: Otsuka Pharmaceutical Europe Ltd
Sponsor class: INDUSTRY
First posted: 2017-04-26
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Persistence (days) with aripiprazole once-monthly
timeFrame: First 6 months after treatment initiation
Secondary outcomes:
measure: Description of reasons of treatment discontinuation (number of discontinuations per reason)
timeFrame: From treatment initiation up to patient inclusion (minimum 6 months)
measure: Change over time in Clinical Global Impressions - Severity (CGI-S) scale
timeFrame: From treatment initiation up to patient inclusion (minimum 6 months)
measure: Change over time in the Brief Psychiatric Rating Scale (BPRS)
timeFrame: From treatment initiation up to patient inclusion (minimum 6 months)
measure: Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings)
timeFrame: From treatment initiation up to patient inclusion (minimum 6 months)
measure: Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
timeFrame: From treatment initiation up to patient inclusion (minimum 6 months)
measure: Description of non-pharmacological interventions aiming to improve functionality (types, numbers of patients per type)
timeFrame: From treatment initiation up to patient inclusion (minimum 6 months)
measure: Description of patterns of alcohol and drug abuse and/or dependence (patterns of drug abuse, type of substance, frequency of consumption)
timeFrame: From treatment initiation up to patient inclusion (minimum 6 months)
Other outcomes:
Locations:
city: Alava
country: Spain
facility: Hospital Universitario de Álava
city: Alcorcón
country: Spain
facility: Hospital Fundación Alcorcón
city: Barcelona
country: Spain
facility: Numància Salut Mental (Parc Sanitari St Joan de Deu)
city: Ciudad Real
country: Spain
facility: Hospital de Ciudad Real
city: Girona
country: Spain
facility: Hospital IAS Girona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari Bellvitge
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: HGU Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Sant Boi de Llobregat
country: Spain
facility: Parc Sanitari St. Joan de Deu (St. Boi)
city: Santiago de Compostela
country: Spain
facility: Hospital Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: Otsuka Europe
name: Medical Department
role: STUDY_DIRECTOR
References:
citation: 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.