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

Sponsor ID
SEP361-123
Clinicaltrials.gov ID
NCT05463770
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-123
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Aug 2022 - Aug 2023
    Healthy Volunteers
    No
    • (this list is not all inclusive)
    • Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
    • Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
    • Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
    • Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
    • Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.
    • (this list is not all inclusive)
    • \-- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).
    • Subject has attempted suicide within 12 months prior to Screening.
    • Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
    • Subject is at risk of harming him/herself or others according to the Investigator's judgment.

    Study Summary

    A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes:

    • how the body processes (uses) glucose (blood sugar)
    • how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body.

    The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose.

    This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    15
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • (this list is not all inclusive)
    • * Male or female subjects between 18 and 65 years of age, inclusive at time of consent.

    Exclusion Criteria

    • (this list is not all inclusive)
    • \-- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • (this list is not all inclusive)
    • Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
    • Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
    • Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
    • Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
    • Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.
    Exclusion Criteria:
    • (this list is not all inclusive)
    • \-- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).
    • Subject has attempted suicide within 12 months prior to Screening.
    • Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
    • Subject is at risk of harming him/herself or others according to the Investigator's judgment.

    Locations

    Location
    Status
    Location
    Woodland International Research Group, LLC
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Woodland Research Northwest, LLC
    Rogers, Arkansas, United States, 72758
    Status
    N/A
    Location
    Collaborative Neuroscience Research, LLC
    Long Beach, California, United States, 90806
    Status
    N/A
    Location
    Catalina Research Institute LLC
    Montclair, California, United States, 91763
    Status
    N/A
    Location
    CNRI - San Diego LLC
    San Diego, California, United States, 92102
    Status
    N/A
    Location
    Galiz Research
    Hialeah, Florida, United States, 33016
    Status
    N/A
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