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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: SEP363856 Clear all
Completed Phase 1 Interventional

A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

NCT05542264
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856, Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
4
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Dayton, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Recruiting Phase 3 Interventional

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

NCT06894212
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
522 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
35
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Rogers, Arkansas + 26 more
Source: ClinicalTrials.gov public record
Updated Jul 30, 2026 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard

NCT05402111
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856, Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
7
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Long Beach, California + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

NCT01940159
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
2
States / cities
Glendale, California • Long Beach, California
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 3 Interventional Results available

A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

NCT04092686
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856 75mg, SEP-363856 100mg, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
464 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
18
States / cities
Rogers, Arkansas • Anaheim, California • Bellflower, California + 15 more
Source: ClinicalTrials.gov public record
Updated Jun 17, 2026 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 2 Interventional

A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

NCT05593029
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
SEP-363856, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
929 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
53
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Tucson, Arizona + 45 more
Source: ClinicalTrials.gov public record
Updated Feb 17, 2026 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 3 Interventional Results available

A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

NCT05628103
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
25
States / cities
Anaheim, California • Bellflower, California • Culver City, California + 19 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2025 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 3 Interventional Results available

A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

NCT04072354
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856 50mg, SEP-363856 75mg, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
13 Years to 65 Years
Enrollment
463 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
18
States / cities
Little Rock, Arkansas • Anaheim, California • Bellflower, California + 13 more
Source: ClinicalTrials.gov public record
Updated May 27, 2026 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 2Phase 3 Interventional

A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

NCT05729373
View directory record Official record
Conditions
Generalized Anxiety Disorder
Interventions
SEP-363856, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
434 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
38
States / cities
Huntsville, Alabama • Phoenix, Arizona • Culver City, California + 29 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2025 · Synced Sep 2, 2026, 10:02 AM EDT
Terminated Phase 3 Interventional

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

NCT04109950
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
13 Years to 65 Years
Enrollment
463 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
25
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Anaheim, California + 19 more
Source: ClinicalTrials.gov public record
Updated Dec 15, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 2 Interventional Results available

An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

NCT02970929
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 40 Years
Enrollment
157 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
6
States / cities
Little Rock, Arkansas • Pico Rivera, California • San Diego, California + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 4, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.

NCT04865835
View directory record Official record
Conditions
Schizophrenia
Interventions
placebo, SEP-363856, metformin
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
2
States / cities
Oakland Park, Florida • Marlton, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 3 Interventional Results available

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

NCT04115319
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP363856, quetiapine XR
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
305 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
18
States / cities
Cerritos, California • Oakland, California • Oceanside, California + 15 more
Source: ClinicalTrials.gov public record
Updated Dec 30, 2025 · Synced Sep 2, 2026, 10:02 AM EDT
Recruiting Phase 3 Interventional

A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder

NCT07759128
View directory record Official record
Conditions
Generalized Anxiety Disorder
Interventions
SEP-363856, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
576 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
3
States / cities
Jacksonville, Florida • New York, New York • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 3 Interventional Results available

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
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
16
States / cities
Anaheim, California • Bellflower, California • Garden Grove, California + 12 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2025 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.

NCT04369391
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP363856 150 mg, Placebo, moxifloxacin 400 mg
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
7
States / cities
Little Rock, Arkansas • Long Beach, California • Pico Rivera, California + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

NCT01994473
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856, Placebo, SEP-363856 Open Label
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
2
States / cities
Glendale, California • Long Beach, California
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis

NCT02969369
View directory record Official record
Conditions
Parkinson Disease Psychosis
Interventions
SEP-363856, Placebo capsule
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 105 Years
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
24
States / cities
Fresno, California • Los Angeles, California • Riverside, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jul 4, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia

NCT02969382
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856, Placebo - Cap
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 40 Years
Enrollment
245 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
6
States / cities
Little Rock, Arkansas • Garden Grove, California • Pico Rivera, California + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 4, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Recruiting Phase 3 Interventional

A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder

NCT07767903
View directory record Official record
Conditions
Generalized Anxiety Disorder
Interventions
SEP-363856, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
384 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
2
States / cities
Cherry Hill, New Jersey • Jamaica, New York
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

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
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
8
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Long Beach, California + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.

NCT05015673
View directory record Official record
Conditions
Narcolepsy
Interventions
SEP363856, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
6
States / cities
Orange, California • St. Petersburg, Florida • Atlanta, Georgia + 3 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT
Completed Phase 1 Interventional

A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

NCT05848700
View directory record Official record
Conditions
Schizophrenia
Interventions
SEP-363856, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
7
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Miami Lakes, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 2, 2026, 10:02 AM EDT