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

Sponsor ID
SEP361-301
Clinicaltrials.gov ID
NCT04072354
EudraCT ID
2019-000470-36
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-301
Trial Details
Subscribe for updates
Age
13 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Sep 2019 - May 2023
    Healthy Volunteers
    No
    • Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
    • Subject or subjects parent/legal guardian \[adolescents\] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
    • Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
    • Subject must have a CGI-S score ≥ 4
    • Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content
    • Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
    • Subject has marked deterioration of functioning in one or more areas.
    • Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.
    • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
    • Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
    • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
    • Female subject who is pregnant or lactating
    • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

    Study Summary

    A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856 50mg
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    463
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
    • 2. Subject or subjects parent/legal guardian \[adolescents\] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..

    Exclusion Criteria

    • 1. Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
    • 2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
    • Subject or subjects parent/legal guardian \[adolescents\] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
    • Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
    • Subject must have a CGI-S score ≥ 4
    • Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content
    • Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
    • Subject has marked deterioration of functioning in one or more areas.
    • Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.
    Exclusion Criteria:
    • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
    • Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
    • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
    • Female subject who is pregnant or lactating
    • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    Research Site
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Research Site
    Anaheim, California, United States, 92805
    Status
    N/A
    Location
    Research Site
    Bellflower, California, United States, 90706
    Status
    N/A
    Location
    Research Site
    Lemon Grove, California, United States, 91945
    Status
    N/A
    Location
    Research Site
    Long Beach, California, United States, 90807
    Status
    N/A
    Location
    Research Site
    Montclair, California, United States, 91763
    Status
    N/A
    Showing {first} - {last} of {total} Results

    © 2026 Otsuka America Pharmaceutical, Inc.

    All rights reserved.

    January 2026 01US25EUC0489

    We defy limitation,

    so that others can too.

    Follow Us
    OAPI and OPDC Locations

    508 Carnegie Center Dr,

    Princeton, NJ 08540, United States

    Phone +1 609-524-6788

    2440 Research Blvd,

    Rockville, MD 20850, United States

    Phone +1 301-424-9055

    3956 Point Eden Way

    Hayward, CA 94545, United States

    Phone +1 800-562-3974