AzTrials
AzTrials

SchizophreniaPhase 3NCT05359081

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

A Phase 3 study testing SEP-363856 in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 51 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
SEP-363856
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
51 sitesJapan
Study dates
16 May 2022to 28 Mar 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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 PANSS total score >=60 at Screening and Baseline.
  • Must have a CGI-S score >=3 at Screening and Baseline
  • 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
  • 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).

Who cannot join

  • 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
  • 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.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

Japan51 sites

  • Takeda General Hospital

    Aizuwakamatsu-shi, Fukushima

  • Heart Care Clinic Omachi

    Akita, Akita

  • Ishigooka Hospital

    Chiba, Chiba

  • Ryokuwakai Stresscare Hibiya Clinic

    Chiyoda-ku, Tokyo

  • Tatsuta Clinic

    Chuo-ku, Kobe-shi, Hyōgo

  • Murakami Hospital

    Edogawa-ku, Tokyo

  • Fukui Hospital

    Fukui-shi, Fukui

  • Ai Sakura Clinic

    Fukuoka, Fukuoka

  • Inokuchi Noma Hospital

    Fukuoka, Fukuoka

  • Kuramitsu Hospital

    Fukuoka, Fukuoka

  • Medical corporation Shinseikai Kaku Mental Clinic

    Fukuoka, Fukuoka

  • Mental Clinic Sakurazaka

    Fukuoka, Fukuoka

  • Seinan Hospital

    Hachinohe-shi, Aomori

  • Kohnodai Hospital National Center for Global Health and Medicine

    Ichikawa-shi, Chiba

  • NHO Hizen Psychiatric Center

    Kanzaki-gun, Saga-ken

  • Rainbow & Sea Hospital

    Karatsu-shi, Saga-ken

  • Kishiro Mental Clinic

    Kawasaki-shi, Kanagawa

  • Musashikosugi J Kokorono Clinic

    Kawasaki-shi, Kanagawa

  • Medical Corporation Kishikai Kishi Hospital

    Kiryu-shi, Gunma

  • Tosa Hospital

    Kochi, Kochi

  • Hotei Hospital

    Konan-shi, Aichi-ken

  • Nishi Kumagaya Hospital

    Kumagaya-shi, Saitama

  • Kouyoudai Hospital

    Kumamoto, Kumamoto

  • Satokai Yuge Hospital

    Kumamoto, Kumamoto

  • NHO Ryukyu Hospital

    Kunigami-gun, Okinawa

  • Hayakawa Clinic

    Kure-shi, Hiroshima

  • NHO Kure Medical Center and Chugoku Cancer Center

    Kure-shi, Hiroshima

  • Ozawa Mental Clinic

    Matsumoto-shi, Nagano

  • Senzoku Psychosomatic Medicine Clinic

    Meguro-ku, Tokyo

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki, Miyazaki

  • Kansai Medical University Medical Center

    Moriguchi-shi, Osaka

  • Keihan Hospital

    Moriguchi-shi, Osaka

  • Akari Clinic

    Naha, Okinawa

  • Miebashi Clinic

    Naha, Okinawa

  • Okayama Psychiatric Medical Center

    Okayama, Okayama-ken

  • Shiranui Hospital

    Omuta-shi, Fukuoka

  • Mental Clinic Minami

    Saitama-shi, Saitama

  • Sanyo Hospital

    Sakata-shi, Yamagata

  • Goryokai Hospital

    Sapporo, Hokkaido

  • Sakura-shinmachi Mental Clinic

    Setagaya-ku, Tokyo

  • Sangenjaya Neurology- Psychosomatic Clinic

    Setagaya-ku, Tokyo

  • Sangubashi Kokorono Clinic

    Shibuya-ku, Tokyo

  • Narimasu Kosei Hospital

    tabashi City, Tokyo

  • Ohwa Mental Clinic

    Toshima-ku, Tokyo

  • Inuo Mental Care Hospital

    Tosu-shi, Saga-ken

  • Barclay Imuro Mental Clinic

    Urasoe-shi, Okinawa

  • Shiroma Clinic

    Urasoe-shi, Okinawa

  • Yamagata Sakuracho Hospital

    Yamagata, Yamagata

  • Hino Hospital

    Yokohama, Kanagawa

  • Miki Mental Clinic

    Yokohama, Kanagawa

  • Yamatenomori Kokorono Clinic

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Conditions
Schizophrenia
Being tested
SEP-363856
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEP-363856Drug

    SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks

Study groups in NCT05359081
Study groupRoleWhat they receive
SEP-363856ExperimentalSEP-363856 (50 or 75 mg/day, flexible dose)
Receives: Drug: SEP-363856

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.

    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.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start16 May 2022
  3. Primary completion21 Mar 2024
  4. Study completion28 Mar 2024

Why it stopped: Due to company business strategy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359081
Sponsor's protocol ID
DA801202
Status last verified
Apr 2024
First submitted
27 Apr 2022
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.

    PubMed 36369028

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SEP-363856 in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 51 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to company business strategy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation. (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in