Trial · NCT05463770
A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia
NCT05463770, Phase 1, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia. Trials, record NCT05463770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05463770
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia
- NCT number
- NCT05463770
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- SEP-363856
- First posted
- 2022-07-19
- Last updated
- 2024-06-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline (PA) in oGTT derived plasma AUC0-120 min of glucose, insulin, c-peptide in oGTT to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | |
| Primary | Change from baseline (PA) in mixed meal tolerance test (MMTT) derived plasma AUC0-240 min of glucose, insulin, c-peptide and β-cell responsivity index to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | |
| Secondary | Change from baseline (PA) in plasma AUC0-240 min and Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | |
| Secondary | Change in Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | |
| Secondary | Change in gastric emptying terminal elimination half-life (T1/2), baseline to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | |
| Secondary | Change in kPCD, baseline to stable dose (SEP-363856) period assessment | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | |
| Secondary | Change in the Visual Analog Scale (VAS) of fullness, hunger and satiety, baseline - repeat test (PA baseline to SEP-363856 stable dose period assessment) for all time points. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | Visual Analog Scale (VAS) is on a scale of 0-100, higher represents higher pain intensity (higher score represents worse outcome). |
| Secondary | Change in lag time, baseline to stable dose (SEP-363856) period assessment | PA Baseline and SEP-363856 Stalbe Dose Period (up to 48 days) |
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.
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/NCT05463770
GET https://conductscience.org/api/trials/v1/NCT05463770/registered