Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
2019年4月9日 更新者：Otsuka Pharmaceutical Europe Ltd
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study
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.
研究概览
地位
未知
条件
详细说明
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.
研究类型
观察性的
注册 (预期的)
636
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alzey、德国
- 撤销
- Rheinhessen-Fachklinik Alzey
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Berlin、德国
- 撤销
- Vivantes Klinikum
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Dusseldorf、德国
- 撤销
- LVR- Klinikum Düsseldorf
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Homburg、德国
- 撤销
- Universitätsklinikum des Saarlandes
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Magdeburg、德国
- 撤销
- Universitätsklinikum Magdeburg
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Taufkirchen、德国
- 撤销
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Ancona、意大利
- 招聘中
- Ospedali Riuniti di Ancona
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Bari、意大利
- 招聘中
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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Camaiore、意大利
- 招聘中
- Ospedale Versilia di Camaiore
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Genzano Di Roma、意大利
- 尚未招聘
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova、意大利
- 招聘中
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina、意大利
- 招聘中
- Mental Health Department (MDSM) ASP di Messina
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Milan、意大利
- 招聘中
- Ospedale Niguarda
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Modena、意大利
- 招聘中
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro、意大利
- 招聘中
- Centro Salute Mentale di Pesaro
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Roma、意大利
- 招聘中
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma、意大利
- 尚未招聘
- Fondazione PTV Policlinico Tor Vergara
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Rome、意大利
- 招聘中
- Villa Maria Dia Hospital
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Salerno、意大利
- 招聘中
- Unit Mental Health District Nº72- ASL Salerno
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Salerno、意大利
- 招聘中
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo、意大利
- 招聘中
- Centro di Salute Mentale
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San Benedetto del Tronto、意大利
- 招聘中
- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano、意大利
- 招聘中
- Dipartimento di Salute Mentale- ASL Napoli
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Teramo、意大利
- 招聘中
- ASL di Teramo
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Clamart、法国
- 撤销
- H. Paul-Guiraud Clamart
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Jonzac、法国
- 撤销
- CH Jonzac
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Laxou、法国
- 撤销
- Centre Psychotherapique Nancy
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Limoges、法国
- 撤销
- Centre Hospitalier Esquirol
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Montpellier、法国
- 招聘中
- CHS-La Colombière
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Nantes、法国
- 撤销
- CHU Nantes Hospital Saint Jacques
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Nice、法国
- 撤销
- CH Sainte Marie
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Nice、法国
- 招聘中
- CHU Pasteur
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Paris、法国
- 招聘中
- Hospital Maison Blanche XX Bichat
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Paris、法国
- 撤销
- Hospital SAINTE ANNE
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Poitiers、法国
- 招聘中
- Centre Hospitalier Henri Laborit
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Rennes、法国
- 招聘中
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne、法国
- 招聘中
- CHU-Saint Etienne
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Saint-Egreve、法国
- 撤销
- Centre Hospitalier Alpes Isère
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Toulon、法国
- 撤销
- CHITS - Hôpital Chalucet
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Vesoul、法国
- 撤销
- CHS St. Remy
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Alcala de Henares、西班牙
- 撤销
- Hospital Príncipe de Asturias
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Barcelona、西班牙
- 招聘中
- Hospital de Sant Pau
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Barcelona、西班牙
- 招聘中
- Hospital del Mar
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Barcelona、西班牙
- 撤销
- Hospital Clínic de Barcelona
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Barcelona、西班牙
- 招聘中
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao、西班牙
- 招聘中
- Hospital Universitario de Cruces
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Girona、西班牙
- 招聘中
- Hospital santa Caterina -IAS
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Granada、西班牙
- 招聘中
- Hospital Campus de la Salud
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Huelva、西班牙
- 撤销
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera、西班牙
- 招聘中
- Hospital de Jerez
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L'Hospitalet de Llobregat、西班牙
- 招聘中
- Hospital Universitari de Bellvitge
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Madrid、西班牙
- 招聘中
- Hospital Universitario 12 de Octubre
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Madrid、西班牙
- 招聘中
- Hospital Fundación Jiménez Díaz
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Madrid、西班牙
- 撤销
- Hospital Clinico San Carlos
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Malaga、西班牙
- 撤销
- Hermanas Hospitalarias de Málaga
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Murcia、西班牙
- 撤销
- Hospital General Universitario Morales Meseguer
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Palma、西班牙
- 招聘中
- Hospital Son Espases
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Sabadell、西班牙
- 撤销
- Hospital Parc Tauli
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Sant Boi de Llobregat、西班牙
- 招聘中
- Hospital Sant Joan de Déu de Sant Boi
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Santander、西班牙
- 招聘中
- Hospital Marqués de Valdecilla
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Toledo、西班牙
- 招聘中
- Hospital Provincial de Toledo
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Valencia、西班牙
- 撤销
- Hospital Clinico Universitario de Valencia
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Valencia、西班牙
- 撤销
- Hospital Universitari i Politecnic La Fe
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Vic、西班牙
- 招聘中
- Hospital de Vic
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Vigo、西班牙
- 招聘中
- Hospital Alvaro Cunqueiro
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Zamora、西班牙
- 撤销
- Hospital Provincial de Zamora
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Cadiz
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Algeciras、Cadiz、西班牙
- 招聘中
- Hospital Punta de Europa
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 35年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Eligible patients will include adult patients (≥18 years) with recent-onset (≤35 years old) schizophrenia who initiated maintenance treatment with AOM or an oral atypical AP during an inpatient stay due to an acute schizophrenia episode or during the immediate three months after hospital discharge and which treatment was initiated before the study start at the site and up to a maximum of 6 months after the launch of AOM in the country.
Prescription of the maintenance treatment had to be done in the usual manner in accordance with the terms of the marketing authorisation.
描述
Inclusion Criteria:
- Adult patients between ≥18 and ≤35 years of age
- Diagnosis of schizophrenia confirmed by the current investigator.
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".
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:
- The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
- Chronically hospitalized patients (defined as more than 3 months).
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Aripiprazole Once Monthly (AOM)
Schizophrenia patients who initiated maintenance treatment with AOM during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
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Daily oral atypical AP
Schizophrenia patients who initiated maintenance treatment with any daily oral atypical AP during a schizophrenia-related hospitalisation or during the first three months after this hospitalisation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
大体时间：First 12 months after initiation of maintenance treatment
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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).
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First 12 months after initiation of maintenance treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
大体时间：First 12 months after initiation of maintenance treatment
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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.
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First 12 months after initiation of maintenance treatment
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Relapse rate (%) in the first 12 months after initiation of maintenance treatment
大体时间：First 12 months after initiation of maintenance treatment
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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.
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First 12 months after initiation of maintenance treatment
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Change over time in CGI-S (score)
大体时间：From index date up to a maximun of 12 months
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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.
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From index date up to a maximun of 12 months
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Change over time in QLS-5 (score)
大体时间：From index date up to a maximun of 12 months
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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.
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From index date up to a maximun of 12 months
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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)
大体时间：From index date up to a maximun of 12 months
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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.
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From index date up to a maximun of 12 months
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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)
大体时间：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.
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From index date up to a maximun of 12 months
|
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Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
大体时间：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.
|
From index date up to a maximun of 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月13日
初级完成 (预期的)
2020年1月31日
研究完成 (预期的)
2020年1月31日
研究注册日期
首次提交
2017年4月21日
首先提交符合 QC 标准的
2017年4月21日
首次发布 (实际的)
2017年4月26日
研究记录更新
最后更新发布 (实际的)
2019年4月11日
上次提交的符合 QC 标准的更新
2019年4月9日
最后验证
2019年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 031-303-00136
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.