A Clinical Study That Will Measure How Well SEP‑363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

Sponsor ID
SEP361-226
Clinicaltrials.gov ID
NCT05729373
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-226
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Anxiety
    • Sex
    Female & Male
    Trial Dates
    Mar 2023 - Sep 2025
    Healthy Volunteers
    No
    • (list is not all inclusive)
    • Male or female subject between 18 to 65 years of age.
    • Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
    • Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.
    • (list is not all inclusive)
    • Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
    • Subjects who report an inadequate response to more than 3 antidepressant treatments
    • Subject is at significant risk of harming self or others based on Investigator's judgment.
    • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
    • Female subject who is pregnant, lactating, or plans to get pregnant during the study.

    Study Summary

    A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.

    Additional Study Details

    Phase
    Phase 2/Phase 3
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    434
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • (list is not all inclusive)
    • * Male or female subject between 18 to 65 years of age.

    Exclusion Criteria

    • (list is not all inclusive)
    • * Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • (list is not all inclusive)
    • Male or female subject between 18 to 65 years of age.
    • Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
    • Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.
    Exclusion Criteria:
    • (list is not all inclusive)
    • Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
    • Subjects who report an inadequate response to more than 3 antidepressant treatments
    • Subject is at significant risk of harming self or others based on Investigator's judgment.
    • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
    • Female subject who is pregnant, lactating, or plans to get pregnant during the study.

    Locations

    Location
    Status
    Location
    University of Alabama at Birmingham
    Huntsville, Alabama, United States, 35801
    Status
    N/A
    Location
    IMA Clinical Research Phoenix
    Phoenix, Arizona, United States, 85012
    Status
    N/A
    Location
    ProScience Research Group
    Culver City, California, United States, 90230
    Status
    N/A
    Location
    Excell Research, Inc.
    Oceanside, California, United States, 92056
    Status
    N/A
    Location
    Anderson Clinical Research
    Redlands, California, United States, 92374
    Status
    N/A
    Location
    California Neuroscience Research, LLC
    Sherman, California, United States, 91403
    Status
    N/A
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