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

Schizophrenia Clinical Trial

— PROSIGO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130478
• Other study ID #: 031-307-00162
• Status: Completed
• Start date: July 18, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2018
• Source: Otsuka Pharmaceutical Europe Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Spain	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	Leon
Spain	Fundación Jiménez Díaz	Madrid
Spain	HGU Gregorio Marañón	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Carlos Haya	Malaga
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	Sevilla
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Europe Ltd

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)