An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP‑363856 in People With Schizophrenia That Switch to SEP‑363856 From Their From Their Current Antipsychotic Medication

Sponsor ID
SEP361-309
Clinicaltrials.gov ID
NCT05741528
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-309
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Mar 2023 - Sep 2024
    Healthy Volunteers
    No
    • (list is not all inclusive)
    • Subject has given written informed consent and privacy authorization prior to participation in the study.
    • Subject has completed the Treatment Period of Study SEP361-308.
    • Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
    • Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
    • (list is not all inclusive)
    • Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
    • Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
    • Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
    • Female subject is pregnant or lactating.

    Study Summary

    An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    75
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • (list is not all inclusive)
    • * Subject has given written informed consent and privacy authorization prior to participation in the study.

    Exclusion Criteria

    • (list is not all inclusive)
    • * Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • (list is not all inclusive)
    • Subject has given written informed consent and privacy authorization prior to participation in the study.
    • Subject has completed the Treatment Period of Study SEP361-308.
    • Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
    • Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
    Exclusion Criteria:
    • (list is not all inclusive)
    • Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
    • Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
    • Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
    • Female subject is pregnant or lactating.

    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
    Anaheim, California, United States, 92805
    Status
    N/A
    Location
    Research Site
    Bellflower, California, United States, 90706
    Status
    N/A
    Location
    Research Site
    Garden Grove, California, United States, 92845
    Status
    N/A
    Location
    Research Site
    Lemon Grove, California, United States, 91945
    Status
    N/A
    Location
    Research Site
    Santee, California, United States, 92071
    Status
    N/A
    Location
    Research Site
    Torrance, California, United States, 90502
    Status
    N/A
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