Trial · NCT05628103
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
NCT05628103, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-11-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT05628103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05628103
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05628103
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 101 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- SEP-363856
- First posted
- 2022-11-28
- Last updated
- 2025-12-11
- Results first posted
- 2025-11-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons | 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. |
| Secondary | Percentage of Participants Who Discontinued From the Study Due to Any Reason | From first dose of the study drug up to end of follow-up period (up to Week 9) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons | From the first dose of the study drug up to end of follow up (up to Week 9) | Safety population included all participants that were enrolled and received the study drug. Percentages are rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Discontinued From the Study Due to Any Reason | From first dose of the 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. Percentages are rounded off to the nearest decimal point. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons | SEP-363856 | 7.9 | 95% Confidence Interval 2.7 to 13.2 | percentage of participants | |
| Percentage of Participants Who Discontinued From the Study Due to Any Reason | SEP-363856 | 17.8 | 95% Confidence Interval 10.4 to 25.3 | percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SEP-363856 | 101 | |
| Overall Study | Safety Population | SEP-363856 | 101 | |
| Overall Study | COMPLETED | SEP-363856 | 83 | |
| Overall Study | NOT COMPLETED | SEP-363856 | 18 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | SEP-363856 | 3 | 101 | |
| other | Nausea | Gastrointestinal disorders | SEP-363856 | 3 | 101 | |
| other | Dizziness | Nervous system disorders | SEP-363856 | 5 | 101 | |
| other | Insomnia | Psychiatric disorders | SEP-363856 | 4 | 101 | |
| serious | Schizophrenia | Psychiatric disorders | SEP-363856 | 4 | 101 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SEP-363856 | 0 | 101 |
| Total, other adverse events | SEP-363856 | 13 | 101 |
| Total, serious adverse events | SEP-363856 | 4 | 101 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05628103
GET https://conductscience.org/api/trials/v1/NCT05628103/registered