Trial · NCT05359081
A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
NCT05359081, Phase 3, Terminated, Sumitomo Pharma Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan. Trials, record NCT05359081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05359081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
- NCT number
- NCT05359081
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Conditions
- Schizophrenia
- Interventions
- SEP-363856
- First posted
- 2022-05-03
- Last updated
- 2025-03-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation. | Week 52 | Evaluate the long-term safety and tolerability of flexible dosed SEP-363856 (50 and 75 mg/day) in subjects with schizophrenia by the incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36369028 | DERIVED |
Source PubMed
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/NCT05359081
GET https://conductscience.org/api/trials/v1/NCT05359081/registered