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

Sponsor ID
SEP361-122
Clinicaltrials.gov ID
NCT05542264
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-122
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Nov 2022 - Feb 2024
    Healthy Volunteers
    No
    • This is not an all inclusive list
    • 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 Positive and negative symptoms scale (PANSS) total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
    • Subject must have a Clinical Global Impressions - Severity (CGI-S) score ≤ 4 (normal to moderately ill) at Screening.
    • Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening.
    • This is not an all inclusive list
    • 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 wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be conducted in approximately 6 study sites in the United States. Participation could last up to 13 weeks.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    19
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

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

    Exclusion Criteria

    • This is not an all inclusive list
    • * 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 is not an all inclusive list
    • 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 Positive and negative symptoms scale (PANSS) total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
    • Subject must have a Clinical Global Impressions - Severity (CGI-S) score ≤ 4 (normal to moderately ill) at Screening.
    • Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening.
    Exclusion Criteria:
    • This is not an all inclusive list
    • 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
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Shari DeSilva
    Rogers, Arkansas, United States, 72758
    Status
    N/A
    Location
    Midwest Clinical Research Center
    Dayton, Ohio, United States, 45417
    Status
    N/A
    Location
    Endeavor Clinical Trials
    San Antonio, Texas, United States, 78240
    Status
    N/A

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