Informations générales (source: ClinicalTrials.gov)
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
Observational
Otsuka Pharmaceutical Europe Ltd (Voir sur ClinicalTrials)
juillet 2017
janvier 2020
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH BICHAT MAISON BLANCHE | Contact (sur clinicalTrials) | ||||
| CHS PAUL GUIRAUD SITE CLAMART | Contact (sur clinicalTrials) | ||||
| GHU PARIS PSY ET NEUROSCIENCES | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Alpes Isere - Saint-Egreve - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Esquirol - Limoges - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Gillaume regnier-CHGR - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Henri laborit - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Centre Psychotherapique Nancy - Laxou - France | Contact (sur clinicalTrials) | ||||
| CH Sainte Marie - Nice - France | Contact (sur clinicalTrials) | ||||
| CHS St. Remy - Vesoul - France | Contact (sur clinicalTrials) | ||||
| CHS-La Colombière - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes Hospital Saint Jacques - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU Pasteur - Nice - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Jonzac - Jonzac - France | Contact (sur clinicalTrials) | ||||
| CHITS - Hôpital Chalucet - Toulon - France | Contact (sur clinicalTrials) | ||||
| CHU-Saint Etienne - Saint Etienne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.
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.