Trial · NCT04038957
A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging
NCT04038957, Phase 1, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2024-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging. Trials, record NCT04038957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04038957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging
- NCT number
- NCT04038957
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Schizophrenia
- Interventions
- SEP-363856
- First posted
- 2019-07-31
- Last updated
- 2024-12-27
- Other registries' IDs
- eudract:2019-000568-65
- Results first posted
- 2024-11-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA. | baseline and week 2 | Dopamine synthesis capacity was assessed using 18 F-DOPA PET(positron emission tomography) scans that were performed before (baseline) and after (Week 2 \[Day 14\]) administration of SEP-363856 adjunctive to an antipsychotic medication. A repeated measures ANOVA(analysis of variance) analysis was conducted. The dependent variable was Dopamine Synthesis Capacity (Ki Values). The independent variables were Time and Striatal Subregion. The covariance matrix was unstructured for each subject's Time and Striatal Subregion. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA. | baseline and week 2 | Kicer | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA. | SEP-363856 | Whole Striatal Dopamine Synthesis Capacity | -0.0007 | Standard Deviation 0.00157 | Kicer |
| Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA. | SEP-363856 | Limbic Striatal Dopamine Synthesis Capacity | -0.0008 | Standard Deviation 0.00118 | Kicer |
| Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA. | SEP-363856 | Associative Striatal Dopamine Synthesis Capacity | -0.0006 | Standard Deviation 0.00158 | Kicer |
| Change From Baseline in Dopamine Synthesis Capacity at Week 2 Using 18F-DOPA. | SEP-363856 | Sensorimotor Striatal Dopamine Synthesis Capacity | -0.0008 | Standard Deviation 0.00207 | Kicer |
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 | 22 | |
| Overall Study | COMPLETED | SEP-363856 | 20 | |
| Overall Study | NOT COMPLETED | SEP-363856 | 2 |
Source ClinicalTrials.gov
Adverse events9
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 | Vision blurred | Eye disorders | SEP-363856 | 2 | 22 | 2 |
| other | Dry mouth | Gastrointestinal disorders | SEP-363856 | 4 | 22 | 4 |
| other | Nausea | Gastrointestinal disorders | SEP-363856 | 3 | 22 | 3 |
| other | Fatigue | General disorders | SEP-363856 | 2 | 22 | 2 |
| other | Dizziness | Nervous system disorders | SEP-363856 | 8 | 22 | 8 |
| other | Headache | Nervous system disorders | SEP-363856 | 4 | 22 | 4 |
| other | Presyncope | Nervous system disorders | SEP-363856 | 2 | 22 | 2 |
| other | Somnolence | Nervous system disorders | SEP-363856 | 14 | 22 | 15 |
| other | Insomnia | Psychiatric disorders | SEP-363856 | 2 | 22 | 2 |
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 | 22 |
| Total, other adverse events | SEP-363856 | 19 | 22 |
| Total, serious adverse events | SEP-363856 | 0 | 22 |
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/NCT04038957
GET https://conductscience.org/api/trials/v1/NCT04038957/registered