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

Sponsor ID
SEP361-302
Clinicaltrials.gov ID
NCT04092686
EudraCT ID
2019-000697-37
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-302
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Oct 2019 - Jun 2023
    Healthy Volunteers
    No
    • Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
    • Participant must give written informed consent and privacy authorization prior to participation in the study.
    • Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing.
    • Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4.
    • Participant must have a Positive and Negative Syndrome Scale (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.
    • Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
    • Participant has marked deterioration of functioning in one or more areas.
    • Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values.
    • Participant 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 on 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.
    • Participant is at significant risk of harming self, others, or objects based on Investigator's judgment.
    • Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study
    • Female participant who is pregnant or lactating
    • Participant has any clinically significant abnormal laboratory value(s) at Screening as determined by 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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856 75mg
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    464
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
    • 2. Participant must give written informed consent and privacy authorization prior to participation in the study.

    Exclusion Criteria

    • 1. Participant 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 on 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. Participant is at significant risk of harming self, others, or objects based on Investigator's judgment.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
    • Participant must give written informed consent and privacy authorization prior to participation in the study.
    • Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing.
    • Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4.
    • Participant must have a Positive and Negative Syndrome Scale (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.
    • Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
    • Participant has marked deterioration of functioning in one or more areas.
    • Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values.
    Exclusion Criteria:
    • Participant 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 on 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.
    • Participant is at significant risk of harming self, others, or objects based on Investigator's judgment.
    • Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study
    • Female participant who is pregnant or lactating
    • Participant has any clinically significant abnormal laboratory value(s) at Screening as determined by 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
    Rogers, Arkansas, United States, 72758
    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
    Culver City, California, United States, 90230
    Status
    N/A
    Location
    Research Site
    Long Beach, California, United States, 90806
    Status
    N/A
    Location
    Research Site
    San Diego, California, United States, 92102
    Status
    N/A
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