Trial · NCT04115319

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

NCT04115319, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-12-31

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. Trials, record NCT04115319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04115319

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
NCT number: NCT04115319
Status: Completed
Phases: Phase 3
Enrollment: 305 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Schizophrenia
Interventions: SEP363856, quetiapine XR
First posted: 2019-10-04
Last updated: 2025-12-31
Other registries' IDs: eudract:2019-002259-40
Results first posted: 2025-12-31

Source ClinicalTrials.gov

Registered outcomes1

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), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	From first dose of the study drug up to 7 days after last dose of study drug (Up to 53 weeks)	An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occured after first administration of study drug were considered AEs. A SAE is an AE that meets one or more criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

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	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	From first dose of the study drug up to 7 days after last dose of study drug (Up to 53 weeks)	Safety population included all participants that were enrolled and received at least 1 dose of study drug during the 52-week treatment period.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	SEP-363856 50 to 100 mg/Day	AEs	153	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	Quetiapine XR 400 to 800 mg/Day	AEs	77	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	SEP-363856 50 to 100 mg/Day	SAEs	16	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	Quetiapine XR 400 to 800 mg/Day	SAEs	0	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	SEP-363856 50 to 100 mg/Day	AEs Leading to Trial Discontinuation	48	Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	Quetiapine XR 400 to 800 mg/Day	AEs Leading to Trial Discontinuation	21	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SEP-363856 50 to 100 mg/Day	203
Overall Study	STARTED	Quetiapine XR 400 to 800 mg/Day	102
Overall Study	COMPLETED	SEP-363856 50 to 100 mg/Day	105
Overall Study	COMPLETED	Quetiapine XR 400 to 800 mg/Day	57
Overall Study	NOT COMPLETED	SEP-363856 50 to 100 mg/Day	98
Overall Study	NOT COMPLETED	Quetiapine XR 400 to 800 mg/Day	45

Source ClinicalTrials.gov

Adverse events40

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 50 to 100 mg/Day	11	201	11
other	Weight decreased	Investigations	Quetiapine XR 400 to 800 mg/Day	1	102	1
other	Weight increased	Investigations	SEP-363856 50 to 100 mg/Day	9	201	9
other	Weight increased	Investigations	Quetiapine XR 400 to 800 mg/Day	11	102	11
other	Akathisia	Nervous system disorders	SEP-363856 50 to 100 mg/Day	14	201	15
other	Akathisia	Nervous system disorders	Quetiapine XR 400 to 800 mg/Day	2	102	2
other	Dizziness	Nervous system disorders	SEP-363856 50 to 100 mg/Day	16	201	18
other	Dizziness	Nervous system disorders	Quetiapine XR 400 to 800 mg/Day	5	102	5
other	Headache	Nervous system disorders	SEP-363856 50 to 100 mg/Day	20	201	29
other	Headache	Nervous system disorders	Quetiapine XR 400 to 800 mg/Day	8	102	8

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SEP-363856 50 to 100 mg/Day	0	201
Total, all-cause mortality	Quetiapine XR 400 to 800 mg/Day	0	102
Total, other adverse events	SEP-363856 50 to 100 mg/Day	103	201
Total, other adverse events	Quetiapine XR 400 to 800 mg/Day	55	102
Total, serious adverse events	SEP-363856 50 to 100 mg/Day	16	201
Total, serious adverse events	Quetiapine XR 400 to 800 mg/Day	0	102

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SEP-363856 50 to 100 mg/Day vs Quetiapine XR 400 to 800 mg/Day: deaths from any cause	Trial comparisons
SEP-363856 50 to 100 mg/Day vs Quetiapine XR 400 to 800 mg/Day: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04115319

GET https://conductscience.org/api/trials/v1/NCT04115319/events?page=2

API reference For AI assistants