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

Sponsor ID
SEP361-121
Clinicaltrials.gov ID
NCT05848700
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-121
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Jun 2023 - Mar 2024
    Healthy Volunteers
    No
    • (this list is not all inclusive)
    • Male or female subject between 18 and 65 years of age (inclusive) at the time of informed 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 Clinical Global Impression-Severity Scale (CGI-S) score ≤ 4 (normal to moderately ill) at Screening and Day 1.
    • 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).
    • Subject has been taking an antipsychotic for at least 6 weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to Screening.
    • (this list is not all inclusive)
    • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
    • Subject has attempted suicide within 6 months prior to Screening.
    • Subject answers "yes" to "Suicidal Ideation" Item 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 Columbia Suicide Severity Rating Scale (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 significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.

    Study Summary

    A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    60
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

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

    Exclusion Criteria

    • (this list is not all inclusive)
    • * Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • (this list is not all inclusive)
    • Male or female subject between 18 and 65 years of age (inclusive) at the time of informed 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 Clinical Global Impression-Severity Scale (CGI-S) score ≤ 4 (normal to moderately ill) at Screening and Day 1.
    • 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).
    • Subject has been taking an antipsychotic for at least 6 weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to Screening.
    Exclusion Criteria:
    • (this list is not all inclusive)
    • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
    • Subject has attempted suicide within 6 months prior to Screening.
    • Subject answers "yes" to "Suicidal Ideation" Item 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 Columbia Suicide Severity Rating Scale (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 significant risk of harming him/herself or others (passive or active) 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
    Rogers, Arkansas, United States, 72758
    Status
    N/A
    Location
    Behavioral Clinical Research, Inc
    Miami Lakes, Florida, United States, 33016
    Status
    N/A
    Location
    Research Centers of America at Fort Lauderdale Behavioral Health Center
    Oakland Park, Florida, United States, 33334
    Status
    N/A
    Location
    Atlanta Center for Medical Research
    Atlanta, Georgia, United States, 30331
    Status
    N/A
    Location
    Neuro-Behavioral Clinical Research, Inc
    North Canton, Ohio, United States, 44720
    Status
    N/A
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