A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

March 16, 2025 updated by: Sumitomo Pharma Co., Ltd.

A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A phase 3, 52-week, open-label study to evaluate the long-term safety and tolerability of SEP-363856 in patients with schizophrenia in Japan. Participants will take flexible dose of SEP-363856 (50 mg/day and 75 mg/day) every night at bedtime for 52 weeks in an open-label manner.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Aichi
      • Konan-shi, Aichi, Japan
        • Hotei Hospital
    • Akita
      • Akita-shi, Akita, Japan
        • Heart Care Clinic Omachi
    • Aomori
      • Hachinohe-shi, Aomori, Japan
        • Seinan Hospital
    • Chiba
      • Chiba-shi, Chiba, Japan
        • Ishigooka Hospital
      • Ichikawa-shi, Chiba, Japan
        • Kohnodai Hospital National Center for Global Health and Medicine
    • Fukui
      • Fukui-shi, Fukui, Japan
        • Fukui Hospital
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
        • Ai Sakura Clinic
      • Fukuoka-shi, Fukuoka, Japan
        • Inokuchi Noma Hospital
      • Fukuoka-shi, Fukuoka, Japan
        • Kuramitsu Hospital
      • Fukuoka-shi, Fukuoka, Japan
        • Medical corporation Shinseikai Kaku Mental Clinic
      • Fukuoka-shi, Fukuoka, Japan
        • Mental Clinic Sakurazaka
      • Omuta-shi, Fukuoka, Japan
        • Shiranui Hospital
    • Fukushima
      • Aizuwakamatsu-shi, Fukushima, Japan
        • Takeda General Hospital
    • Gunma
      • Kiryu-shi, Gunma, Japan
        • Medical Corporation Kishikai Kishi Hospital
    • Hiroshima
      • Kure-shi, Hiroshima, Japan
        • Hayakawa Clinic
      • Kure-shi, Hiroshima, Japan
        • NHO Kure Medical Center and Chugoku Cancer Center
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
        • Goryokai Hospital
    • Hyogo
      • Chuo-ku, Kobe-shi, Hyogo, Japan
        • Tatsuta Clinic
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan
        • Kishiro Mental Clinic
      • Kawasaki-shi, Kanagawa, Japan
        • Musashikosugi J Kokorono Clinic
      • Yokohama-shi, Kanagawa, Japan
        • Hino Hospital
      • Yokohama-shi, Kanagawa, Japan
        • Miki Mental Clinic
      • Yokohama-shi, Kanagawa, Japan
        • Yamatenomori Kokorono Clinic
    • Kochi
      • Kochi-shi, Kochi, Japan
        • Tosa Hospital
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
        • Kouyoudai Hospital
      • Kumamoto-shi, Kumamoto, Japan
        • Satokai Yuge Hospital
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan
        • Miyazaki Prefectural Miyazaki Hospital
    • Nagano
      • Matsumoto-shi, Nagano, Japan
        • Ozawa Mental Clinic
    • Okayama
      • Okayama-shi, Okayama, Japan
        • Okayama Psychiatric Medical Center
    • Okinawa
      • Kunigami-gun, Okinawa, Japan
        • NHO Ryukyu Hospital
      • Naha-shi, Okinawa, Japan
        • Akari Clinic
      • Naha-shi, Okinawa, Japan
        • Miebashi Clinic
      • Urasoe-shi, Okinawa, Japan
        • Barclay Imuro Mental Clinic
      • Urasoe-shi, Okinawa, Japan
        • Shiroma Clinic
    • Osaka
      • Moriguchi-shi, Osaka, Japan
        • Kansai Medical University Medical Center
      • Moriguchi-shi, Osaka, Japan
        • Keihan Hospital
    • Saga
      • Kanzaki-gun, Saga, Japan
        • NHO Hizen Psychiatric Center
      • Karatsu-shi, Saga, Japan
        • Rainbow & Sea Hospital
      • Tosu-shi, Saga, Japan
        • Inuo Mental Care Hospital
    • Saitama
      • Kumagaya-shi, Saitama, Japan
        • Nishi Kumagaya Hospital
      • Saitama-shi, Saitama, Japan
        • Mental Clinic Minami
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan
        • Ryokuwakai Stresscare Hibiya Clinic
      • Edogawa-ku, Tokyo, Japan
        • Murakami Hospital
      • Itabashi-ku, Tokyo, Japan
        • Narimasu Kosei Hospital
      • Meguro-ku, Tokyo, Japan
        • Senzoku Psychosomatic Medicine Clinic
      • Setagaya-ku, Tokyo, Japan
        • Sakura-shinmachi Mental Clinic
      • Setagaya-ku, Tokyo, Japan
        • Sangenjaya Neurology- Psychosomatic Clinic
      • Shibuya-ku, Tokyo, Japan
        • Sangubashi Kokorono Clinic
      • Toshima-ku, Tokyo, Japan
        • Ohwa Mental Clinic
    • Yamagata
      • Sakata-shi, Yamagata, Japan
        • Sanyo Hospital
      • Yamagata-shi, Yamagata, Japan
        • Yamagata Sakuracho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  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 PANSS total score >=60 at Screening and Baseline.
  5. Must have a CGI-S score >=3 at Screening and Baseline
  6. Judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Baseline and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening
  7. In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination, 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 or substance (other than nicotine or caffeine) use disorder within past 12 months or for a total of >= 10 years during the subject's lifetime, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SEP-363856
SEP-363856 (50 or 75 mg/day, flexible dose)
Drug: SEP-363856
SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.
Time Frame: Week 52
Evaluate the long-term safety and tolerability of flexible dosed SEP-363856 (50 and 75 mg/day) in subjects with schizophrenia by the incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sumitomo Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DA801202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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