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

NCT03130478 | Completed

• 1 other identifier: 031-307-00162
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 15

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.

Conditions

Schizophrenia

Keywords

long-acting injectable antipsychotic; persistence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Description of reasons of treatment discontinuation (number of discontinuations per reason)

  From treatment initiation up to patient inclusion (minimum 6 months)

• Change over time in Clinical Global Impressions - Severity (CGI-S) scale

  From treatment initiation up to patient inclusion (minimum 6 months)

• Change over time in the Brief Psychiatric Rating Scale (BPRS)

  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)

  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)

  From treatment initiation up to patient inclusion (minimum 6 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Europe Ltd: lead

Study Sites (15)

Hospital Universitario de Álava

Alava, Spain

Location

Hospital Fundación Alcorcón

Alcorcón, Spain

Location

Numància Salut Mental (Parc Sanitari St Joan de Deu)

Barcelona, Spain

Location

Hospital de Ciudad Real

Ciudad Real, Spain

Location

Hospital IAS Girona

Girona, Spain

Location

Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Spain

Location

Complejo Asistencial Universitario de Leon

León, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

HGU Gregorio Marañón

Madrid, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Parc Sanitari St. Joan de Deu (St. Boi)

Sant Boi de Llobregat, Spain

Location

Hospital Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Spain

Location

Related Publications (1)

• 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.

  PMID: 33840396 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Medical Department

  Otsuka Europe

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: July 18, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)