Trial · NCT05741528
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
NCT05741528, 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. An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication. Trials, record NCT05741528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05741528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
- NCT number
- NCT05741528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- SEP-363856
- First posted
- 2023-02-23
- Last updated
- 2025-12-11
- Results first posted
- 2025-11-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. |
| Primary | Number of Participants With Serious Adverse Events | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event is any AE occurring at any dose that results in death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization, or is a congenital anomaly/birth defect. |
| Primary | Number of Participants With AEs Leading to Discontinuation of Study | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs leading to discontinuation from the study are those AEs which caused participant to discontinue from the study. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Discontinuation of Study | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | SEP-363856 | 28 | Participants | ||
| Number of Participants With Serious Adverse Events | SEP-363856 | 4 | Participants | ||
| Number of Participants With AEs Leading to Discontinuation of Study | SEP-363856 | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SEP-363856 | 75 | |
| Overall Study | COMPLETED | SEP-363856 | 56 | |
| Overall Study | NOT COMPLETED | SEP-363856 | 19 |
Source ClinicalTrials.gov
Adverse events6
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 | Weight decreased | Investigations | SEP-363856 | 5 | 75 | |
| other | C-reactive protein increased | Investigations | SEP-363856 | 4 | 75 | |
| serious | Delusion | Psychiatric disorders | SEP-363856 | 1 | 75 | |
| serious | Psychotic disorder | Psychiatric disorders | SEP-363856 | 1 | 75 | |
| serious | Schizophrenia | Psychiatric disorders | SEP-363856 | 1 | 75 | |
| serious | Hypotension | Vascular disorders | SEP-363856 | 1 | 75 |
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 | 75 |
| Total, other adverse events | SEP-363856 | 9 | 75 |
| Total, serious adverse events | SEP-363856 | 4 | 75 |
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/NCT05741528
GET https://conductscience.org/api/trials/v1/NCT05741528/registered