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

NCT ID: NCT03130478

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-18
• Study Completion Date: 2018-07-30

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).

Conditions

Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Europe Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Department

Role: STUDY_DIRECTOR

Otsuka Europe

Locations

Hospital Universitario de Álava

Alava, , Spain

Hospital Fundación Alcorcón

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

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33840396 (View on PubMed)

Other Identifiers

031-307-00162

Identifier Type: -

Identifier Source: org_study_id