SchizophreniaPhase 3NCT06894212
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
A Phase 3 study testing SEP-363856 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 2 countries.
Trial summary
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia 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?
- Yes, some participants may receive a placebo
- How many people
- 538 participants
- Where
- 73 sitesin 2 countries
- Study dates
- 28 Feb 2025to 29 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
73 sites in 2 countries.
73 sites in 2 countries
Japan38 sites
National Hospital Organization Shimofusa Psychiatric Medical Center
Chiba, Chiba, 266-0007
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Kuramitsu Hospital
Fukuoka, Fukuoka, 819-0037
Seijinkai Seinan Hospital
Hachinohe-shi, Aomori, 039-1104
Hatano Kousei Hospital
Hadano-shi, Kanagawa, 257-0003
Tanzawa Hospital
Hadano-shi, Kanagawa, 259-1304
Fujimidai Hospital Site
Hiratsuka-shi, Kanagawa, 259-1205
National Kohnodai Medical Center
Ichikawa-shi, Chiba, 272-8516
National Hospital Organization Hizen Psychiatric Medical Center Site
Kanzaki-gun, Saga-ken, 842-0192
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031
National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo, 187-8551
National Hospital Organization Kokura Medical Center Site
Kokuraminami-ku, Kitakyushu-shi, Fukuoka, 802-8533
Hotei Hospital
Konan-shi, Aichi-ken, 483-8248
Social Medical Corporation Asaka Hospital
Kōriyama, Fukushima, 963-0198
Yuge Hospital
Kumamoto, Kumamoto, 861-8002
Hayakawa Clinic
Kure, Hiroshima, 737-0111
NHO Kure Medical Center
Kure-shi, Hiroshima, 737-0023
Asuka Hospital
Machida-shi, Tokyo, 194-0005
Miyakonojo Shinsei Hospital
Miyakonojo-shi, Miyazaki, 885-0093
Kansai Medical University Medical Center
Moriguchi-shi, Osaka, 570-8507
Nayoro City General Hospital
Nayoro-shi, Hokkaido, 096-8511
Neyagawa Sanatorium
Neyagawa, Osaka, 572-0854
Obihiro Kosei Hospital
Obihiro, Hokkaido, 080-0024
Shiranui Hospital
Omuta-shi, Fukuoka, 836-0004
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192
Sanyo Hospital
Sakata-shi, Yamagata, 998-0074
Goryokai Medical Corporation Hospital
Sapporo, Hokkaido, 002-8029
Showa Medical University Karasuyama Hospital
Setagaya-ku, Tokyo, 157-8577
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, 329-0498
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695
Inuo Hospital
Tosu-shi, Saga-ken, 841-0081
Toyama Prefectural Center Hospital
Toyama, Toyama, 930-8550
Seishinkai Okehazama Hospital
Toyoake-shi, Aichi-ken, 470-1168
Tochigi Prefectural Okamotodai Hospital
Utsunomiya, Tochigi, 329-1104
Wakayama Medical University Hospital
Wakayama, 641-8510
Yamagata Sakuracho Hospital Site
Yamagata, Yamagata, 990-0045
Yokohama Hino Hospital
Yokohama, Kanagawa, 234-0051
United States35 sites
Synexus Clinical Research US Inc - Atlanta
Atlanta, Georgia, 30328
CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
Atlanta, Georgia, 30331
Community Clinical Research Inc
Austin, Texas, 78754
Clinical Innovations, Inc. dba CITrials (Bellflower)
Bellflower, California, 90706
Pillar Clinical Research LLC - Bentonville Site
Bentonville, Arkansas, 72712
Uptown Research Institute
Chicago, Illinois, 60640
Pillar Clinical Research LLC (Chicago)
Chicago, Illinois, 60641
ProScience Research Group Site
Culver City, California, 90230
CenExel IRA (CenExcel iResearch, LLC) Site
Decatur, Georgia, 30030
InSite Clinical Research
DeSoto, Texas, 75115
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
Garden Grove, California, 92845
Galiz Research Site
Hialeah, Florida, 33016
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
Hollywood, Florida, 33021
Cenexel RCA (Research Centers of America) Site
Hollywood, Florida, 33024
HD Research - Memorial Hermann Surgery Center Memorial Village
Houston, Texas, 77043
Synergy San Diego Site
Lemon Grove, California, 91945
Pillar Clinical Research (Little Rock AR) Site
Little Rock, Arkansas, 72204
Woodland International Research Group Site
Little Rock, Arkansas, 72211
Hassman Research Institute, LLC
Marlton, New Jersey, 20877
Premier Clinical Research Institute
Miami, Florida, 33122
D & H National Research Centers NC
Miami, Florida, 33155
Innovative Clinical Research, Inc. Site
Miami Lakes, Florida, 33016
Catalina Research Institute Site
Montclair, California, 91763
Eastern Clinical Research Associates
New Orleans, Louisiana, 70127
Neuro-Behavioral Clinical Research Site
North Canton, Ohio, 44720
Accelerated Clinical Trials in Peachtree Corners GA Site
Peachtree Corners, Georgia, 30071
Pillar Clinical Research LLC (Richardson, TX) Site
Richardson, Texas, 75080
Clinical Innovations Inc. DBA CITrials (Riverside)
Riverside, California, 92506
Richmond Behavioral Associates LLC
Riverside, California, 92506
Woodland Research Northwest Site
Rogers, Arkansas, 72758
CNRI - San Diego LLC Site
San Diego, California, 92123
Schuster Medical Research Institute
Sherman Oaks, California, 91403
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
Torrance, California, 90504
Health Synergy Clinical Research LLC Site
West Palm Beach, Florida, 33407
About this study
Official title: 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
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Read the detailed description
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
- Conditions
- Schizophrenia
- Being tested
- SEP-363856, Placebo
- 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
tablet
PlaceboOther
tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| SEP-363856 75 mg | Experimental | SEP-363856 75 mg/day Receives: Drug: SEP-363856 |
| SEP-363856 100 mg | Experimental | SEP-363856 100 mg/day Receives: Drug: SEP-363856 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at 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
Measured: Baseline to Week 6
Secondary outcomes (1)
Clinical Global Impression-Severity (CGI-S)
Change from baseline in CGI-S score at Week 6.
CGI-S is 0-7 with higher score is indicative of greater symptomatology
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start28 Feb 2025
- Primary completion20 Oct 2026 (estimated)
- Study completion29 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894212
- Sponsor's protocol ID
- 382-201-00035
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06894212
- Acronym / sponsor ID
- 382-201-00035
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| SEP-363856 75 mg | Experimental | Drug: SEP-363856SEP-363856 75 mg/day |
| SEP-363856 100 mg | Experimental | Drug: SEP-363856SEP-363856 100 mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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:
- AND
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEP-363856tablet | Drug | SEP-363856 100 mg, SEP-363856 75 mg |
| Placebotablet | Other | Placebo |
Primary outcome
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
Time frame: 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
1 secondary outcome
Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Otsuka Clinical Trials websiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
73 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SEP-363856 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 73 sites in 2 countries.
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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Japan, United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6 (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.