정신 분열증을 앓고있는 심리적 정신병자 참가자에서 Sep-363856의 효능과 안전성에 대한 시험
정신 분열증을 앓고있는 급성 정신병자 참가자에서 Sep-363856의 효능 및 안전성을 평가하기 위해 무작위, 이중 맹검, 평행 한 그룹, 위약 대조, 다기관 시험
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
연구 개요
상세 설명
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Arkansas
-
Bentonville, Arkansas, 미국, 72712
- Pillar Clinical Research LLC - Bentonville Site
-
Little Rock, Arkansas, 미국, 72204
- Pillar Clinical Research (Little Rock AR) Site
-
Little Rock, Arkansas, 미국, 72211
- Woodland International Research Group Site
-
Rogers, Arkansas, 미국, 72758
- Woodland Research Northwest Site
-
-
California
-
Bellflower, California, 미국, 90706
- Clinical Innovations, Inc. dba CITrials (Bellflower)
-
Culver City, California, 미국, 90230
- ProScience Research Group Site
-
Garden Grove, California, 미국, 92845
- CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
-
Lemon Grove, California, 미국, 91945
- Synergy San Diego Site
-
Montclair, California, 미국, 91763
- Catalina Research Institute Site
-
Riverside, California, 미국, 92506
- Clinical Innovations Inc. DBA CITrials (Riverside)
-
Riverside, California, 미국, 92506
- Richmond Behavioral Associates LLC
-
San Diego, California, 미국, 92123
- CNRI - San Diego LLC Site
-
Sherman Oaks, California, 미국, 91403
- Schuster Medical Research Institute
-
Torrance, California, 미국, 90504
- CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
-
-
Florida
-
Hialeah, Florida, 미국, 33016
- Galiz Research Site
-
Hollywood, Florida, 미국, 33021
- Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
-
Hollywood, Florida, 미국, 33024
- Cenexel RCA (Research Centers of America) Site
-
Miami, Florida, 미국, 33122
- Premier Clinical Research Institute
-
Miami, Florida, 미국, 33155
- D & H National Research Centers NC
-
Miami Lakes, Florida, 미국, 33016
- Innovative Clinical Research, Inc. Site
-
West Palm Beach, Florida, 미국, 33407
- Health Synergy Clinical Research LLC Site
-
-
Georgia
-
Atlanta, Georgia, 미국, 30328
- Synexus Clinical Research US Inc - Atlanta
-
Atlanta, Georgia, 미국, 30331
- CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
-
Decatur, Georgia, 미국, 30030
- CenExel IRA (CenExcel iResearch, LLC) Site
-
Peachtree Corners, Georgia, 미국, 30071
- Accelerated Clinical Trials in Peachtree Corners GA Site
-
-
Illinois
-
Chicago, Illinois, 미국, 60640
- Uptown Research Institute
-
Chicago, Illinois, 미국, 60641
- Pillar Clinical Research LLC (Chicago)
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70127
- Eastern Clinical Research Associates
-
-
Maryland
-
Gaithersburg, Maryland, 미국, 20877
- Cenexel CBH (CBH Health)
-
-
New Jersey
-
Marlton, New Jersey, 미국, 20877
- Hassman Research Institute, LLC
-
-
Ohio
-
North Canton, Ohio, 미국, 44720
- Neuro-Behavioral Clinical Research Site
-
-
Texas
-
Austin, Texas, 미국, 78754
- Community Clinical Research Inc
-
DeSoto, Texas, 미국, 75115
- InSite Clinical Research
-
Houston, Texas, 미국, 77043
- HD Research - Memorial Hermann Surgery Center Memorial Village
-
Richardson, Texas, 미국, 75080
- Pillar Clinical Research LLC (Richardson, TX) Site
-
-
-
-
-
Wakayama, 일본, 641-8510
- Wakayama Medical University Hospital
-
-
Aichi-ken
-
Konan-shi, Aichi-ken, 일본, 483-8248
- Hotei Hospital
-
Toyoake-shi, Aichi-ken, 일본, 470-1168
- Seishinkai Okehazama Hospital
-
-
Aomori
-
Hachinohe-shi, Aomori, 일본, 039-1104
- Seijinkai Seinan Hospital
-
-
Chiba
-
Chiba, Chiba, 일본, 266-0007
- National Hospital Organization Shimofusa Psychiatric Medical Center
-
Ichikawa-shi, Chiba, 일본, 272-8516
- National Kohnodai Medical Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, 일본, 814-0180
- Fukuoka University Hospital
-
Fukuoka, Fukuoka, 일본, 819-0037
- Kuramitsu Hospital
-
Kokuraminami-ku, Kitakyushu-shi, Fukuoka, 일본, 802-8533
- National Hospital Organization Kokura Medical Center Site
-
Omuta-shi, Fukuoka, 일본, 836-0004
- Shiranui Hospital
-
-
Fukushima
-
Kōriyama, Fukushima, 일본, 963-0198
- Social Medical Corporation Asaka Hospital
-
-
Hiroshima
-
Kure, Hiroshima, 일본, 737-0111
- Hayakawa Clinic
-
Kure-shi, Hiroshima, 일본, 737-0023
- NHO Kure Medical Center
-
-
Hokkaido
-
Nayoro-shi, Hokkaido, 일본, 096-8511
- Nayoro City General Hospital
-
Obihiro, Hokkaido, 일본, 080-0024
- Obihiro Kosei Hospital
-
Sapporo, Hokkaido, 일본, 002-8029
- Goryokai Medical Corporation Hospital
-
-
Iwate
-
Shiwa-gun, Iwate, 일본, 028-3695
- Iwate Medical University Hospital
-
-
Kanagawa
-
Hadano-shi, Kanagawa, 일본, 257-0003
- Hatano Kousei Hospital
-
Hadano-shi, Kanagawa, 일본, 259-1304
- Tanzawa Hospital
-
Hiratsuka-shi, Kanagawa, 일본, 259-1205
- Fujimidai Hospital Site
-
Yokohama, Kanagawa, 일본, 234-0051
- Yokohama Hino Hospital
-
-
Kumamoto
-
Kumamoto, Kumamoto, 일본, 861-8002
- Yuge Hospital
-
-
Miyazaki
-
Miyakonojo-shi, Miyazaki, 일본, 885-0093
- Miyakonojo Shinsei Hospital
-
-
Osaka
-
Moriguchi-shi, Osaka, 일본, 570-8507
- Kansai Medical University Medical Center
-
Neyagawa, Osaka, 일본, 572-0854
- Neyagawa Sanatorium
-
-
Saga-ken
-
Kanzaki-gun, Saga-ken, 일본, 842-0192
- National Hospital Organization Hizen Psychiatric Medical Center Site
-
Karatsu-shi, Saga-ken, 일본, 847-0031
- Rainbow and Sea Hospital
-
Tosu-shi, Saga-ken, 일본, 841-0081
- Inuo Hospital
-
-
Shiga
-
Ōtsu, Shiga, 일본, 520-2192
- Shiga University of Medical Science Hospital
-
-
Tochigi
-
Shimotsuga-gun, Tochigi, 일본, 321-0293
- Dokkyo Medical University Hospital
-
Shimotsuke-Shi, Tochigi, 일본, 329-0498
- Jichi Medical University Hospital
-
Utsunomiya, Tochigi, 일본, 329-1104
- Tochigi Prefectural Okamotodai Hospital
-
-
Tokyo
-
Kodaira-shi, Tokyo, 일본, 187-8551
- National Center of Neurology and Psychiatry
-
Machida-shi, Tokyo, 일본, 194-0005
- Asuka Hospital
-
Setagaya-ku, Tokyo, 일본, 157-8577
- Showa Medical University Karasuyama Hospital
-
-
Toyama
-
Toyama, Toyama, 일본, 930-8550
- Toyama Prefectural Center Hospital
-
-
Yamagata
-
Sakata-shi, Yamagata, 일본, 998-0074
- Sanyo Hospital
-
Yamagata, Yamagata, 일본, 990-0045
- Yamagata Sakuracho Hospital Site
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
-
Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
-
Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
-
Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
- The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
- If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
-
Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
-
Participant must have a PANSS total score ≥ 80
AND
-
Participant must have a CGI-S score ≥ 4.
-
-
Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
Key Exclusion Criteria:
- Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
- Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo
Placebo |
tablet |
|
실험적: SEP-363856 75 mg
SEP-363856 75 mg/day |
tablet |
|
실험적: SEP-363856 100 mg
SEP-363856 100 mg/day |
tablet |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
기간: Baseline to Week 6
|
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology |
Baseline to Week 6
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
기간: Baseline to Week 6
|
Change from baseline in CGI-S score at Week 6. CGI-S is 0-7 with higher score is indicative of greater symptomatology |
Baseline to Week 6
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 382-201-00035
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Anonymized Individual participant data (IPD) that underlie the result of this study will be shared with researchers to achieve aims pre-specified in a methodology sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD 공유 기간
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD 공유 액세스 기준
Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .