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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEP-363856 | Drug | SEP-363856 flexibly dosed for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first dose of the study drug up to end of follow up (up to Week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: This list is not all inclusive
Exclusion Criteria:This list is not all inclusive
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Center, Inc. | Anaheim | California | 92805 | United States | ||
| Clinical Innovations Inc. |
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.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
A total of 243 participants were screened, of which 101 participants entered the study, and all 101 participants received at least one dose of SEP-363856 in the 8-week treatment period.
Participants took part in the study at 26 clinical sites in the United States (US) from 19 December 2022 to 01 April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | SEP-363856 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2023 | Oct 29, 2025 |
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| From first dose of the study drug up to end of follow-up period (up to Week 9) |
| Bellflower |
| California |
| 90706 |
| United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Collaborative Neuroscience Research, LLC | Garden Grove | California | 92845 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Clinical Innovations, Inc | Riverside | California | 92506 | United States |
| California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) | San Diego | California | 92102 | United States |
| CMB Clinical Trials | Santee | California | 92071 | United States |
| Cenexel CNS Research | Torrance | California | 90502 | United States |
| Larkin Behavioral Health Services | Hollywood | Florida | 33021 | United States |
| Premier Clinical Research Institute, Inc. | Miami | Florida | 33122 | United States |
| Wellness Research Center | Miami | Florida | 33135 | United States |
| Nova Psychiatry, Inc. | Orlando | Florida | 32803 | United States |
| Advanced Discovery Research LLC | Atlanta | Georgia | 30318 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Atlanta Behavioral Research | Atlanta | Georgia | 30358 | United States |
| Uptown Research | Chicago | Illinois | 60640 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | United States |
| IMA Clinical Research | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | United States |
| Clinical Trials of America, LLC | Hickory | North Carolina | 28601 | United States |
| Charak Clinical Research Center | Garfield Heights | Ohio | 44125 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants that were enrolled and received the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SEP-363856 | Participants received flexible doses of SEP-363856 50 to 100 mg/day, orally, 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population included all participants that were enrolled and received the study drug. Percentages are rounded off to the nearest decimal point. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of the study drug up to end of follow up (up to Week 9) |
|
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| Secondary | 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. | Safety population included all participants that were enrolled and received the study drug. Percentages are rounded off to the nearest decimal point. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of the study drug up to end of follow-up period (up to Week 9) |
|
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From first dose of study drug up to end of follow up period (up to Week 9)
Safety population included all participants that were enrolled and received the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SEP-363856 | Participants received flexible doses of SEP-363856 50 to 100 mg/day, orally, 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. | 0 | 101 | 4 | 101 | 13 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-800-441-6763 | smb_clinicaltranspa@otsuka-us.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2024 | Oct 29, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705647 | SEP-363856 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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