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A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SEP-363856 50 mg
SEP-363856 75 mg
Placebo
Sponsored by
Sumitomo Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities. If the subject is considered a minor according to local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
  2. Male or female between 18 to 65 years of age (inclusive) at the time of consent.
  3. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
  4. Must have a CGI S score ≥ 4 (moderately ill) at Screening and Baseline.
  5. Must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), and unusual thought content (G9) at Screening and Baseline.
  6. Must have an acute exacerbation of psychotic symptoms (no longer than 2 months prior to providing informed consent for this study). The acute exacerbation should include:

    a. Marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.

  7. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination (PE), vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis).

Exclusion Criteria:

  1. Have a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment
  2. At significant risk of harming self, others, or objects based on Investigator's judgment.
  3. Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
  4. Female subjects who are pregnant or lactating.
  5. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.

Sites / Locations

  • Beijing Anding Hospital Capital Medical UniversityRecruiting
  • Peking University Sixth HospitalRecruiting
  • The Affiliated Brain Hospital of Guangzhou Medical UniversityRecruiting
  • The Second People's Hospital of Hunan Province/ Brain Hospital of Hunan ProvinceRecruiting
  • Shandong Daizhuang HospitalRecruiting
  • Shanghai Mental Health CenterRecruiting
  • The Mental Health Center of Xi'anRecruiting
  • Tianjin Anding HospitalRecruiting
  • Hotei HospitalRecruiting
  • Okehazama Hospital Fujita Kokoro Care CenterRecruiting
  • Medical corporation Seijinkai Seinan HospitalRecruiting
  • Kohnodai Hp., National Center for Global Health and MedicineRecruiting
  • Shiranui HospitalRecruiting
  • Juzenkai Oorin HospitalRecruiting
  • Takeda General HospitalRecruiting
  • Mihara HospitalRecruiting
  • Fujimidai HospitalRecruiting
  • Okinawa Tokushukai Hino HospitalRecruiting
  • Yatsushiro Kosei HospitalRecruiting
  • Miyakonojo Shinsei HospitalRecruiting
  • Shonan HospitalRecruiting
  • Mental Support Soyokaze HospitalRecruiting
  • NHO Ryukyu HospitalRecruiting
  • Social welfare corporation Tenshinkai Kosaka hospitalRecruiting
  • Kansai Medical University Medical CenterRecruiting
  • Nishiurakai Keihan HospitalRecruiting
  • Neyagawa SanatoriumRecruiting
  • Asakayama HospitalRecruiting
  • Osaka Institute of Clinical Psychiatry Shin-abuyama HospitalRecruiting
  • NHO Hizen Psychiatric CenterRecruiting
  • Rainbow & Sea HospitalRecruiting
  • Nishi Kumagaya HospitalRecruiting
  • Shiga university of medical science hospitalRecruiting
  • Negishi HospitalRecruiting
  • Narimasu Kosei HospitalRecruiting
  • National Center of Neurology and PsychiatryRecruiting
  • National Hospital Organization Hokuriku National HospitalRecruiting
  • Azusakai Kawada HospitalRecruiting
  • Sanyokai Sanyo HospitalRecruiting
  • Akino HospitalRecruiting
  • Akita City HospitalRecruiting
  • Inokuchi Noma HospitalRecruiting
  • Kuramitsu HospitalRecruiting
  • Minkodo Aburayama HospitalRecruiting
  • Satokai Yuge HospitalRecruiting
  • Miyazaki Prefectural Miyazaki HospitalRecruiting
  • Mariveles Mental Wellness and General HospitalRecruiting
  • St. Paul's Hospital of Iloilo, Inc.Recruiting
  • Makati Medical CenterRecruiting
  • National Center for Mental HealthRecruiting
  • Southern Philippines Medical CenterRecruiting
  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationRecruiting
  • Kaohsiung Municipal Kai-Syuan Psychiatric HospitalRecruiting
  • Chang Gung Memorial Hospital, KeelungRecruiting
  • Jianan Psychiatric Center, Ministry of Health and WelfareRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SEP-363856 50 mg/day

SEP-363856 75 mg/day

Placebo

Arm Description

Subjects randomized to the SEP-363856 50 mg/day group will receive the assigned dose of SEP-363856 50 mg/day throughout the double-blind phase.

Subjects randomized to the SEP-363856 75 mg/day group will receive SEP-363856 50 mg/day on Day 1 through Day 3 and then the assigned dose of SEP-363856 75 mg/day thereafter.

Subjects randomized to the placebo group will receive placebo throughout the double-blind phase.

Outcomes

Primary Outcome Measures

Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Week 6
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.

Secondary Outcome Measures

Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Week 6
The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.

Full Information

First Posted
March 29, 2021
Last Updated
July 12, 2023
Sponsor
Sumitomo Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04825860
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase
Official Title
A Randomized, Double-blind, Parallel-group, Placebo Controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in Acutely Psychotic Patients With Schizophrenia, Followed by an Open-label Extension Phase
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A clinical study to investigate the effect of 2 doses of an investigational drug in acutely psychotic adult patients with schizophrenia. The study will consist of a double-blind phase followed by an open-label extension phase.
Detailed Description
A Phase 2/3 Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Patients with Schizophrenia, Followed by an Open-label Extension Phase. The double-blind phase is to evaluate the efficacy and safety of 2 doses of SEP-363856 (50 and 75 mg/day) versus placebo over 6 weeks in acutely psychotic patients with schizophrenia. This phase is projected to randomize approximately 480 subjects to 3 treatments (SEP-363856 50 mg/day, SEP-363856 75 mg/day, placebo) in a 1:1:1 ratio. The completers of the double-blind phase will be able to enroll into the 12-week open-label phase during which the long term safety and effectiveness of-SEP 363856 will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856 50 mg/day
Arm Type
Experimental
Arm Description
Subjects randomized to the SEP-363856 50 mg/day group will receive the assigned dose of SEP-363856 50 mg/day throughout the double-blind phase.
Arm Title
SEP-363856 75 mg/day
Arm Type
Experimental
Arm Description
Subjects randomized to the SEP-363856 75 mg/day group will receive SEP-363856 50 mg/day on Day 1 through Day 3 and then the assigned dose of SEP-363856 75 mg/day thereafter.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to the placebo group will receive placebo throughout the double-blind phase.
Intervention Type
Drug
Intervention Name(s)
SEP-363856 50 mg
Intervention Description
Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
Intervention Type
Drug
Intervention Name(s)
SEP-363856 75 mg
Intervention Description
Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
Primary Outcome Measure Information:
Title
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Week 6
Description
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Week 6
Description
The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities. If the subject is considered a minor according to local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject. Male or female between 18 to 65 years of age (inclusive) at the time of consent. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening Must have a CGI S score ≥ 4 (moderately ill) at Screening and Baseline. Must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), and unusual thought content (G9) at Screening and Baseline. Must have an acute exacerbation of psychotic symptoms (no longer than 2 months prior to providing informed consent for this study). The acute exacerbation should include: a. Marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination (PE), vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis). Exclusion Criteria: Have a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment At significant risk of harming self, others, or objects based on Investigator's judgment. Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study. Female subjects who are pregnant or lactating. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sumitomo Pharma Co., Ltd.
Phone
E-mail only
Email
cc@sumitomo-pharma.co.jp
Facility Information:
Facility Name
Beijing Anding Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Dong
Phone
+861058303236
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyan Zhang
Phone
+861062723762
Facility Name
The Affiliated Brain Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuping Ning
Phone
+862081898313
Facility Name
The Second People's Hospital of Hunan Province/ Brain Hospital of Hunan Province
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenghua Fang
Phone
+8673185230846
Facility Name
Shandong Daizhuang Hospital
City
Jining
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinguo Zhai
Phone
+865373165029
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanjun Li
Phone
+862134773656
Facility Name
The Mental Health Center of Xi'an
City
Xian
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Wu
Phone
+862963609241
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Wang
Phone
+862288188036
Facility Name
Hotei Hospital
City
Konan
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masashi Takakura
Phone
+81587557251
Facility Name
Okehazama Hospital Fujita Kokoro Care Center
City
Toyoake
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Fujita
Phone
+81562971361
Facility Name
Medical corporation Seijinkai Seinan Hospital
City
Hachinohe
State/Province
Aomori
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Fukasawa
Facility Name
Kohnodai Hp., National Center for Global Health and Medicine
City
Ichikawa
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetsuro Enomoto
Phone
+81473723501
Facility Name
Shiranui Hospital
City
Omuta
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michihiko Matsushita
Phone
+81944552000
Facility Name
Juzenkai Oorin Hospital
City
Onojo
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiko Ishibashi
Phone
+81925811445
Facility Name
Takeda General Hospital
City
Aizu-Wakamatsu
State/Province
Fukushima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koichi Osonoe
Phone
+81242275511
Facility Name
Mihara Hospital
City
Mihara
State/Province
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Oyamada
Phone
+81848638877
Facility Name
Fujimidai Hospital
City
Hiratsuka
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takafumi Yahoko
Phone
+81463580186
Facility Name
Okinawa Tokushukai Hino Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsuomi Baba
Phone
+81458438511
Facility Name
Yatsushiro Kosei Hospital
City
Yatsushiro
State/Province
Kumamoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenshiro Miyamoto
Phone
+81965334205
Facility Name
Miyakonojo Shinsei Hospital
City
Miyakonojo
State/Province
Miyazaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiko Kawano
Phone
+81986220280
Facility Name
Shonan Hospital
City
Matsumoto
State/Province
Nagano
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshio Miyasaka
Phone
+81263252303
Facility Name
Mental Support Soyokaze Hospital
City
Ueda
State/Province
Nagano
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomotaka Yoshida
Phone
+81268350305
Facility Name
NHO Ryukyu Hospital
City
Kunigami
State/Province
Okinawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taku Otsuru
Phone
+81989682133
Facility Name
Social welfare corporation Tenshinkai Kosaka hospital
City
Higashiosaka
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hitoshi Azuma
Phone
+81667225151
Facility Name
Kansai Medical University Medical Center
City
Moriguchi
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiteru Takekita
Facility Name
Nishiurakai Keihan Hospital
City
Moriguchi
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Nishiura
Phone
+81669082019
Facility Name
Neyagawa Sanatorium
City
Neyagawa
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naohiko Matsumoto
Phone
+81728223561
Facility Name
Asakayama Hospital
City
Sakai
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norio Taniguchi
Phone
+81722294882
Facility Name
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
City
Takatsuki
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroki Kikuyama
Phone
+81726931881
Facility Name
NHO Hizen Psychiatric Center
City
Kanzaki
State/Province
Saga
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryo Murakawa
Phone
+81952523231
Facility Name
Rainbow & Sea Hospital
City
Karatsu
State/Province
Saga
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taro Shindo
Phone
+81955770711
Facility Name
Nishi Kumagaya Hospital
City
Kumagaya
State/Province
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayato Suzuki
Phone
+81485220200
Facility Name
Shiga university of medical science hospital
City
Otsu
State/Province
Shiga
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Ozeki
Phone
+81775482111
Facility Name
Negishi Hospital
City
Fuchu
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taisuke Ido
Facility Name
Narimasu Kosei Hospital
City
Itabashi
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuya Tenjin
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoki Yoshimura
Facility Name
National Hospital Organization Hokuriku National Hospital
City
Nanto
State/Province
Toyama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Shiraishi
Phone
+81763621340
Facility Name
Azusakai Kawada Hospital
City
Takaoka
State/Province
Toyama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiwamu Hiroyasu
Phone
+81766233737
Facility Name
Sanyokai Sanyo Hospital
City
Sakata
State/Province
Yamagata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuto Kobayashi
Phone
+81234333355
Facility Name
Akino Hospital
City
Tendo
State/Province
Yamagata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osami Kinoshita
Phone
+81236535725
Facility Name
Akita City Hospital
City
Akita
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shingo Naito
Phone
+81188234171
Facility Name
Inokuchi Noma Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hironobu Matsuoka
Facility Name
Kuramitsu Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noriko Tamaru
Phone
+81928111821
Facility Name
Minkodo Aburayama Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makoto Irisawa
Phone
+81928712261
Facility Name
Satokai Yuge Hospital
City
Kumamoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiro Shono
Phone
+81963383838
Facility Name
Miyazaki Prefectural Miyazaki Hospital
City
Miyazaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiro Kawano
Phone
+81985244181
Facility Name
Mariveles Mental Wellness and General Hospital
City
Mariveles
State/Province
Bataan
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joeffrey Cruzada
Facility Name
St. Paul's Hospital of Iloilo, Inc.
City
Iloilo City
State/Province
Iloilo
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rowena Cosca
Phone
+63333372742
Facility Name
Makati Medical Center
City
Makati
State/Province
Metro Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luzviminda Katigbak
Phone
+63288888999
Facility Name
National Center for Mental Health
City
Mandaluyong
State/Province
Metro Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noel Reyes
Phone
+63285319001
Facility Name
Southern Philippines Medical Center
City
Davao
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Padilla
Phone
+63822272731
Facility Name
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Hualien City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shao-Tsu Chen
Phone
+88638561825
Facility Name
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-Ting Hsu
Phone
+88677513171
Facility Name
Chang Gung Memorial Hospital, Keelung
City
Keelung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Yen Chen
Phone
+886224313131
Facility Name
Jianan Psychiatric Center, Ministry of Health and Welfare
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun-Chia Chang
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzung-Jeng Hwang
Phone
+886223123456
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya-Mei Bai
Phone
+886228712121

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

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