Sep-363856在精神分裂症急性精神病参与者中的功效和安全性试验
第3阶段，随机，双盲，平行组，安慰剂对照，多中心试验，以评估SEP-363856在精神分裂症的急性精神病参与者中的疗效和安全性
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Wakayama、日本、641-8510
- Wakayama Medical University Hospital
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Aichi-ken
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Konan-shi、Aichi-ken、日本、483-8248
- Hotei Hospital
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Toyoake-shi、Aichi-ken、日本、470-1168
- Seishinkai Okehazama Hospital
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Aomori
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Hachinohe-shi、Aomori、日本、039-1104
- Seijinkai Seinan Hospital
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Chiba
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Chiba、Chiba、日本、266-0007
- National Hospital Organization Shimofusa Psychiatric Medical Center
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Ichikawa-shi、Chiba、日本、272-8516
- National Kohnodai Medical Center
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Fukuoka
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Fukuoka、Fukuoka、日本、814-0180
- Fukuoka University Hospital
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Fukuoka、Fukuoka、日本、819-0037
- Kuramitsu Hospital
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Kokuraminami-ku, Kitakyushu-shi、Fukuoka、日本、802-8533
- National Hospital Organization Kokura Medical Center Site
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Omuta-shi、Fukuoka、日本、836-0004
- Shiranui Hospital
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Fukushima
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Kōriyama、Fukushima、日本、963-0198
- Social Medical Corporation Asaka Hospital
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Hiroshima
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Kure、Hiroshima、日本、737-0111
- Hayakawa Clinic
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Kure-shi、Hiroshima、日本、737-0023
- NHO Kure Medical Center
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Hokkaido
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Nayoro-shi、Hokkaido、日本、096-8511
- Nayoro City General Hospital
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Obihiro、Hokkaido、日本、080-0024
- Obihiro Kosei Hospital
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Sapporo、Hokkaido、日本、002-8029
- Goryokai Medical Corporation Hospital
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Iwate
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Shiwa-gun、Iwate、日本、028-3695
- Iwate Medical University Hospital
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Kanagawa
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Hadano-shi、Kanagawa、日本、257-0003
- Hatano Kousei Hospital
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Hadano-shi、Kanagawa、日本、259-1304
- Tanzawa Hospital
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Hiratsuka-shi、Kanagawa、日本、259-1205
- Fujimidai Hospital Site
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Yokohama、Kanagawa、日本、234-0051
- Yokohama Hino Hospital
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Kumamoto
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Kumamoto、Kumamoto、日本、861-8002
- Yuge Hospital
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Miyazaki
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Miyakonojo-shi、Miyazaki、日本、885-0093
- Miyakonojo Shinsei Hospital
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Osaka
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Moriguchi-shi、Osaka、日本、570-8507
- Kansai Medical University Medical Center
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Neyagawa、Osaka、日本、572-0854
- Neyagawa Sanatorium
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Saga-ken
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Kanzaki-gun、Saga-ken、日本、842-0192
- National Hospital Organization Hizen Psychiatric Medical Center Site
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Karatsu-shi、Saga-ken、日本、847-0031
- Rainbow and Sea Hospital
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Tosu-shi、Saga-ken、日本、841-0081
- Inuo Hospital
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Shiga
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Ōtsu、Shiga、日本、520-2192
- Shiga University of Medical Science Hospital
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Tochigi
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Shimotsuga-gun、Tochigi、日本、321-0293
- Dokkyo Medical University Hospital
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Shimotsuke-Shi、Tochigi、日本、329-0498
- Jichi Medical University Hospital
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Utsunomiya、Tochigi、日本、329-1104
- Tochigi Prefectural Okamotodai Hospital
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Tokyo
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Kodaira-shi、Tokyo、日本、187-8551
- National Center of Neurology and Psychiatry
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Machida-shi、Tokyo、日本、194-0005
- Asuka Hospital
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Setagaya-ku、Tokyo、日本、157-8577
- Showa Medical University Karasuyama Hospital
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Toyama
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Toyama、Toyama、日本、930-8550
- Toyama Prefectural Center Hospital
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Yamagata
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Sakata-shi、Yamagata、日本、998-0074
- Sanyo Hospital
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Yamagata、Yamagata、日本、990-0045
- Yamagata Sakuracho Hospital Site
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Arkansas
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Bentonville、Arkansas、美国、72712
- Pillar Clinical Research LLC - Bentonville Site
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Little Rock、Arkansas、美国、72204
- Pillar Clinical Research (Little Rock AR) Site
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Little Rock、Arkansas、美国、72211
- Woodland International Research Group Site
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Rogers、Arkansas、美国、72758
- Woodland Research Northwest Site
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California
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Bellflower、California、美国、90706
- Clinical Innovations, Inc. dba CITrials (Bellflower)
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Culver City、California、美国、90230
- ProScience Research Group Site
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Garden Grove、California、美国、92845
- CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
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Lemon Grove、California、美国、91945
- Synergy San Diego Site
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Montclair、California、美国、91763
- Catalina Research Institute Site
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Riverside、California、美国、92506
- Clinical Innovations Inc. DBA CITrials (Riverside)
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Riverside、California、美国、92506
- Richmond Behavioral Associates LLC
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San Diego、California、美国、92123
- CNRI - San Diego LLC Site
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Sherman Oaks、California、美国、91403
- Schuster Medical Research Institute
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Torrance、California、美国、90504
- CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
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Florida
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Hialeah、Florida、美国、33016
- Galiz Research Site
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Hollywood、Florida、美国、33021
- Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
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Hollywood、Florida、美国、33024
- Cenexel RCA (Research Centers of America) Site
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Miami、Florida、美国、33122
- Premier Clinical Research Institute
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Miami、Florida、美国、33155
- D & H National Research Centers NC
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Miami Lakes、Florida、美国、33016
- Innovative Clinical Research, Inc. Site
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West Palm Beach、Florida、美国、33407
- Health Synergy Clinical Research LLC Site
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Georgia
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Atlanta、Georgia、美国、30328
- Synexus Clinical Research US Inc - Atlanta
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Atlanta、Georgia、美国、30331
- CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
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Decatur、Georgia、美国、30030
- CenExel IRA (CenExcel iResearch, LLC) Site
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Peachtree Corners、Georgia、美国、30071
- Accelerated Clinical Trials in Peachtree Corners GA Site
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Illinois
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Chicago、Illinois、美国、60640
- Uptown Research Institute
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Chicago、Illinois、美国、60641
- Pillar Clinical Research LLC (Chicago)
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Louisiana
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New Orleans、Louisiana、美国、70127
- Eastern Clinical Research Associates
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Maryland
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Gaithersburg、Maryland、美国、20877
- Cenexel CBH (CBH Health)
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New Jersey
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Marlton、New Jersey、美国、20877
- Hassman Research Institute, LLC
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Ohio
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North Canton、Ohio、美国、44720
- Neuro-Behavioral Clinical Research Site
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Texas
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Austin、Texas、美国、78754
- Community Clinical Research Inc
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DeSoto、Texas、美国、75115
- InSite Clinical Research
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Houston、Texas、美国、77043
- HD Research - Memorial Hermann Surgery Center Memorial Village
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Richardson、Texas、美国、75080
- Pillar Clinical Research LLC (Richardson, TX) Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
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Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
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Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
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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.
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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:
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Participant must have a PANSS total score ≥ 80
AND
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Participant must have a CGI-S score ≥ 4.
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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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Placebo
Placebo |
tablet |
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实验性的：SEP-363856 75 mg
SEP-363856 75 mg/day |
tablet |
|
实验性的：SEP-363856 100 mg
SEP-363856 100 mg/day |
tablet |
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 |
|---|---|---|
|
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
大体时间：Baseline to Week 6
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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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical Global Impression-Severity (CGI-S)
大体时间：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
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- 382-201-00035
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享时间框架
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 共享访问标准
Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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