Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia

• Conditions: Schizophrenia

• Registration Number: NCT03130465
• Lead Sponsor: Otsuka Pharmaceutical Europe Ltd

Brief Summary

This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

Detailed Description

This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

The date of maintenance treatment initiation will be considered the index date (see definition of maintenance treatment initiation in Section 3.1). Baseline data will be collected immediately after the inclusion of the patient in the study (including retrospective data from the index date to the date of informed consent and from the past 5 years). From the index date, each patient will be followed up until discontinuation of the maintenance treatment of interest and up to a maximum of 12 months. Especially after the implementation of the Global Amendment nº1, it is possible that the complete follow-up of the patient took place in the past (retrospective data), i.e. before the inclusion of the subject in the study. Data will be collected from the patient file and from information obtained during routine visits scheduled according to clinical practice.

Study Timeline

• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Study Start: 2017-07-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 636

Inclusion Criteria

1. Adult patients between ≥18 and ≤35 years of age

2. Diagnosis of schizophrenia confirmed by the current investigator.

3. Initiation of maintenance treatment with AOM (at least one injection) or with daily oral atypical AP before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country, during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge, and prescribed in the usual manner in accordance with the terms of the marketing authorisation.*

   Patients treated in the daycare hospital will be considered:

   • Eligible to be included, if the patient was admitted in the hospital (full time inpatient stay) for an acute psychotic episode and then discharged to a day care hospital in order to achieve stabilization and initiate maintenance antipsychotic treatment. The initiation of the maintenance antipsychotic treatment (index date) must occur before discharge from day care hospital or during the immediate following three months after discharge.

   • NOT eligible, if the patient was treated exclusively in the day care hospital since the first day (i.e. not spending any night at all in the hospital) as these patients are very likely to be subacutely psychotic.

     • The date of initiation of maintenance therapy will be considered the index date. For AOM, it is the date of the first injection. For the oral AP, this date is defined by the physician when patients are believed to be stable enough to be considered "in maintenance treatment".

4. Willingness to participate in the study; subjects must give their written consent to participate unless: they have discontinued treatment or have finished the 12 months follow up period before study inclusion (retrospective assessment only) and a) written consent not required by local regulations, or b) it would take a non-reasonable effort† or c) 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 local regulations/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 (defined as more than 3 months).
3. Participation in an interventional clinical trial since AOM or daily oral atypical AP were initiated as maintenance treatment or within the previous 6 months to this initiation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP	First 12 months after initiation of maintenance treatment	Treatment discontinuation is defined as the interruption, replacement or addition of a new antipsychotic drug to the main antipsychotic initiated at index date (AOM or daily oral atypical AP).

Secondary Outcome Measures

Name	Time	Method
Change over time in CGI-S (score)	From index date up to a maximun of 12 months	To compare the evolution in disease severity according to Clinical Global Impression-Disease Severity (CGI-S) scale from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
Change over time in QLS-5 (score)	From index date up to a maximun of 12 months	To compare the clinical and functional outcomes according to the 5-item Quality of Life Scale for schizophrenia (QLS-5) from initiation of maintenance treatment and up to the end of follow-up (12 months or up to discontinuation) between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP as maintenance treatment.
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation	First 12 months after initiation of maintenance treatment	To compare the treatment discontinuation rate and the reasons for this discontinuation during the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
Relapse rate (%) in the first 12 months after initiation of maintenance treatment	First 12 months after initiation of maintenance treatment	To compare the relapse rate in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
All-cause hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first all-cause hospitalisation and length of hospitalisation(admission/discharge dates)	From index date up to a maximun of 12 months	To compare all cause hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
Mental health-related hospitalisation rate (%) in the first 12 months after initiation of maintenance treatment, time to first mental health-related hospitalisation and length of mental-health related hospitalisation (admission/discharge dates)	From index date up to a maximun of 12 months	To compare mental health-related hospitalisations in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)	From index date up to a maximun of 12 months	To compare the health resource use related to schizophrenia in the first 12 months after initiation of maintenance treatment between patients with recent-onset schizophrenia treated with AOM or with a daily oral atypical AP.

Trial Locations

Locations (67)

H. Paul-Guiraud Clamart; 🇫🇷 Clamart, France

CH Jonzac; 🇫🇷 Jonzac, France

Centre Psychotherapique Nancy; 🇫🇷 Laxou, France

Centre Hospitalier Esquirol; 🇫🇷 Limoges, France

CHS-La Colombière; 🇫🇷 Montpellier, France

CHU Nantes Hospital Saint Jacques; 🇫🇷 Nantes, France

CH Sainte Marie; 🇫🇷 Nice, France

CHU Pasteur; 🇫🇷 Nice, France

Hospital Maison Blanche XX Bichat; 🇫🇷 Paris, France

Hospital Sainte Anne; 🇫🇷 Paris, France

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