A Clinical Study That Will Evaluate How Well SEP‑363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP‑363856 From Their Current Antipsychotic Medication

Sponsor ID
SEP361-308
Clinicaltrials.gov ID
NCT05628103
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-308
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Dec 2022 - Apr 2024
    Healthy Volunteers
    No
    • This list is not all inclusive
    • Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
    • Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
    • Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
    • Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
    • This list is not all inclusive
    • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
    • Participants are at significant risk of harming self or others 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 tests positive for drugs of abuse at Screening.

    Study Summary

    This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    101
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • This list is not all inclusive
    • * Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.

    Exclusion Criteria

    • This list is not all inclusive
    • * Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • This list is not all inclusive
    • Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
    • Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
    • Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
    • Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
    Exclusion Criteria:
    • This list is not all inclusive
    • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
    • Participants are at significant risk of harming self or others 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 tests positive for drugs of abuse at Screening.

    Study Documents

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

    Locations

    Location
    Status
    Location
    Advanced Research Center, Inc.
    Anaheim, California, United States, 92805
    Status
    N/A
    Location
    Clinical Innovations Inc.
    Bellflower, California, United States, 90706
    Status
    N/A
    Location
    ProScience Research Group
    Culver City, California, United States, 90230
    Status
    N/A
    Location
    Collaborative Neuroscience Research, LLC
    Garden Grove, California, United States, 92845
    Status
    N/A
    Location
    Synergy San Diego
    Lemon Grove, California, United States, 91945
    Status
    N/A
    Location
    Clinical Innovations, Inc
    Riverside, California, United States, 92506
    Status
    N/A
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