Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia
2019년 4월 9일 업데이트: 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.
연구 개요
상태
알려지지 않은
정황
상세 설명
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.
연구 유형
관찰
등록 (예상)
636
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alzey, 독일
- 빼는
- Rheinhessen-Fachklinik Alzey
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Berlin, 독일
- 빼는
- Vivantes Klinikum
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Dusseldorf, 독일
- 빼는
- LVR- Klinikum Düsseldorf
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Homburg, 독일
- 빼는
- Universitätsklinikum des Saarlandes
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Magdeburg, 독일
- 빼는
- Universitätsklinikum Magdeburg
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Taufkirchen, 독일
- 빼는
- Kbo-Isar-Ampere-Klinikum Taufkirchen
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Alcala de Henares, 스페인
- 빼는
- Hospital Príncipe de Asturias
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Barcelona, 스페인
- 모병
- Hospital de Sant Pau
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Barcelona, 스페인
- 모병
- Hospital del Mar
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Barcelona, 스페인
- 빼는
- Hospital Clínic de Barcelona
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Barcelona, 스페인
- 모병
- IINA (Instituto Internacional de Neurociencias Aplicadas)
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Bilbao, 스페인
- 모병
- Hospital Universitario de Cruces
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Girona, 스페인
- 모병
- Hospital santa Caterina -IAS
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Granada, 스페인
- 모병
- Hospital Campus de la Salud
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Huelva, 스페인
- 빼는
- Hospital Juan Ramón Jimenez
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Jerez de la Frontera, 스페인
- 모병
- Hospital de Jerez
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L'Hospitalet de Llobregat, 스페인
- 모병
- Hospital Universitari de Bellvitge
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Madrid, 스페인
- 모병
- Hospital Universitario 12 de Octubre
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Madrid, 스페인
- 모병
- Hospital Fundación Jiménez Díaz
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Madrid, 스페인
- 빼는
- Hospital Clinico San Carlos
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Malaga, 스페인
- 빼는
- Hermanas Hospitalarias de Málaga
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Murcia, 스페인
- 빼는
- Hospital General Universitario Morales Meseguer
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Palma, 스페인
- 모병
- Hospital Son Espases
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Sabadell, 스페인
- 빼는
- Hospital Parc Tauli
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Sant Boi de Llobregat, 스페인
- 모병
- Hospital Sant Joan de Déu de Sant Boi
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Santander, 스페인
- 모병
- Hospital Marqués de Valdecilla
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Toledo, 스페인
- 모병
- Hospital Provincial de Toledo
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Valencia, 스페인
- 빼는
- Hospital Clinico Universitario de Valencia
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Valencia, 스페인
- 빼는
- Hospital Universitari i Politecnic La Fe
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Vic, 스페인
- 모병
- Hospital de Vic
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Vigo, 스페인
- 모병
- Hospital Alvaro Cunqueiro
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Zamora, 스페인
- 빼는
- Hospital Provincial de Zamora
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Cadiz
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Algeciras, Cadiz, 스페인
- 모병
- Hospital Punta de Europa
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Ancona, 이탈리아
- 모병
- Ospedali Riuniti di Ancona
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Bari, 이탈리아
- 모병
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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Camaiore, 이탈리아
- 모병
- Ospedale Versilia di Camaiore
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Genzano Di Roma, 이탈리아
- 아직 모집하지 않음
- Cura Neuropsichiatria Villa Von Siebenthal
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Giulianova, 이탈리아
- 모병
- P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura
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Messina, 이탈리아
- 모병
- Mental Health Department (MDSM) ASP di Messina
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Milan, 이탈리아
- 모병
- Ospedale Niguarda
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Modena, 이탈리아
- 모병
- Dipartimento di Salute Mentale -ASL Modena
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Pesaro, 이탈리아
- 모병
- Centro Salute Mentale di Pesaro
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Roma, 이탈리아
- 모병
- Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria
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Roma, 이탈리아
- 아직 모집하지 않음
- Fondazione PTV Policlinico Tor Vergara
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Rome, 이탈리아
- 모병
- Villa Maria Dia Hospital
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Salerno, 이탈리아
- 모병
- Unit Mental Health District Nº72- ASL Salerno
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Salerno, 이탈리아
- 모병
- Unita Operativa- Salute Mentale di Salerno
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Saluzzo, 이탈리아
- 모병
- Centro di Salute Mentale
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San Benedetto del Tronto, 이탈리아
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- Ospedale Madonna del Soccorso San Bendedetto del Tronto
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San Giorgio a Cremano, 이탈리아
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- Dipartimento di Salute Mentale- ASL Napoli
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Teramo, 이탈리아
- 모병
- ASL di Teramo
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Clamart, 프랑스
- 빼는
- H. Paul-Guiraud Clamart
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Jonzac, 프랑스
- 빼는
- CH Jonzac
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Laxou, 프랑스
- 빼는
- Centre Psychotherapique Nancy
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Limoges, 프랑스
- 빼는
- Centre Hospitalier Esquirol
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Montpellier, 프랑스
- 모병
- CHS-La Colombière
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Nantes, 프랑스
- 빼는
- CHU Nantes Hospital Saint Jacques
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Nice, 프랑스
- 빼는
- CH Sainte Marie
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Nice, 프랑스
- 모병
- CHU Pasteur
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Paris, 프랑스
- 모병
- Hospital Maison Blanche XX Bichat
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Paris, 프랑스
- 빼는
- Hospital SAINTE ANNE
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Poitiers, 프랑스
- 모병
- Centre Hospitalier Henri Laborit
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Rennes, 프랑스
- 모병
- Centre Hospitalier Gillaume regnier-CHGR
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Saint Etienne, 프랑스
- 모병
- CHU-Saint Etienne
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Saint-Egreve, 프랑스
- 빼는
- Centre Hospitalier Alpes Isère
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Toulon, 프랑스
- 빼는
- CHITS - Hôpital Chalucet
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Vesoul, 프랑스
- 빼는
- CHS St. Remy
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time (days) to all-cause treatment discontinuation for AOM or daily oral atypical AP
기간: 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).
|
First 12 months after initiation of maintenance treatment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment discontinuation rate (%) and description of the reasons for treatment discontinuation
기간: 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.
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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
기간: 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.
|
First 12 months after initiation of maintenance treatment
|
|
Change over time in CGI-S (score)
기간: 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.
|
From index date up to a maximun of 12 months
|
|
Change over time in QLS-5 (score)
기간: 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.
|
From index date up to a maximun of 12 months
|
|
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)
기간: 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.
|
From index date up to a maximun of 12 months
|
|
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)
기간: 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.
|
From index date up to a maximun of 12 months
|
|
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 7월 13일
기본 완료 (예상)
2020년 1월 31일
연구 완료 (예상)
2020년 1월 31일
연구 등록 날짜
최초 제출
2017년 4월 21일
QC 기준을 충족하는 최초 제출
2017년 4월 21일
처음 게시됨 (실제)
2017년 4월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 4월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 9일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 031-303-00136
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .