SchizophreniaPhase 3NCT05628103
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication
A Phase 3 study testing SEP-363856 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 25 sites in United States.
Trial summary
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. 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
- 101 participants
- Where
- 25 sitesUnited States
- Study dates
- 19 Dec 2022to 1 Apr 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
- Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
- Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
- Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
Who cannot join
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
- Participants are at significant risk of harming self or others based on investigator's judgment.
- Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
- Female participant who is pregnant or lactating.
- Participant tests positive for drugs of abuse at Screening.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
Advanced Discovery Research LLC
Atlanta, Georgia, 30318
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Atlanta Behavioral Research
Atlanta, Georgia, 30358
Clinical Innovations Inc.
Bellflower, California, 90706
Hassman Research Institute
Berlin, New Jersey, 08009
New Hope Clinical Research
Charlotte, North Carolina, 28211
Uptown Research
Chicago, Illinois, 60640
ProScience Research Group
Culver City, California, 90230
CBH Health
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Research, LLC
Garden Grove, California, 92845
Charak Clinical Research Center
Garfield Heights, Ohio, 44125
Clinical Trials of America, LLC
Hickory, North Carolina, 28601
Larkin Behavioral Health Services
Hollywood, Florida, 33021
IMA Clinical Research
Las Vegas, Nevada, 89102
Synergy San Diego
Lemon Grove, California, 91945
Premier Clinical Research Institute, Inc.
Miami, Florida, 33122
Wellness Research Center
Miami, Florida, 33135
Nova Psychiatry, Inc.
Orlando, Florida, 32803
Pillar Clinical Research, LLC
Richardson, Texas, 75080
Clinical Innovations, Inc
Riverside, California, 92506
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
San Diego, California, 92102
CMB Clinical Trials
Santee, California, 92071
PsychCare Consultants Research
St Louis, Missouri, 63128
Cenexel CNS Research
Torrance, California, 90502
About this study
Official title: An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
Read the detailed description
This was an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study.
Following a screening period of up to 21 days, eligible participants took part in the study. In the 8-week treatment period, participants were treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants were required to complete the follow-up visit, 7 days after the last dose of SEP-363856.
- Conditions
- Schizophrenia
- Being tested
- SEP-363856
- Keywords
- Schizophrenia
- 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 flexibly dosed for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SEP-363856 | Experimental | Participants received flexible doses of SEP-363856 50 to 100 milligrams per day (mg/day), orally, once daily (QD) up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8. Receives: Drug: SEP-363856 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons
Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% confidence interval (CI). 95% CI was calculated using the normal approximation method.
Measured: From the first dose of the study drug up to end of follow up (up to Week 9)
Secondary outcomes (1)
Percentage of Participants Who Discontinued From the Study Due to Any Reason
The percentage of participants who discontinued from the study due to any reason was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to any reason as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% CI. 95% CI was calculated using the normal approximation method.
Measured: From first dose of the study drug up to end of follow-up period (up to Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start19 Dec 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628103
- Sponsor's protocol ID
- SEP361-308
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2022
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
- ClinicalTrials.gov ID
- NCT05628103
- Acronym / sponsor ID
- SEP361-308
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
Detailed description
This was an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study.
Following a screening period of up to 21 days, eligible participants took part in the study. In the 8-week treatment period, participants were treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants were required to complete the follow-up visit, 7 days after the last dose of SEP-363856.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEP-363856 | Experimental | Drug: SEP-363856Participants received flexible doses of SEP-363856 50 to 100 milligrams per day (mg/day), orally, once daily (QD) up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
- Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
- Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
- Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
Key exclusion criteria (5 listed)
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
- Participants are at significant risk of harming self or others based on investigator's judgment.
- Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
- Female participant who is pregnant or lactating.
- Participant tests positive for drugs of abuse at Screening.
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-363856SEP-363856 flexibly dosed for 8 weeks. | Drug | SEP-363856 |
Primary outcome
Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons
Time frame: From the first dose of the study drug up to end of follow up (up to Week 9)
Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% confidence interval (CI). 95% CI was calculated using the normal approximation method.
1 secondary outcome
Percentage of Participants Who Discontinued From the Study Due to Any Reason
Time frame: From first dose of the study drug up to end of follow-up period (up to Week 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically 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.
25 sites in 1 country: 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 25 sites in United States.
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 4 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: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in 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. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons (time frame: From the first dose of the study drug up to end of follow up (up to Week 9)). 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 11 Dec 2025.