A Trial of the Efficacy and Safety of Fixed Doses of SEP‑363856 in Adults With Generalized Anxiety Disorder

Sponsor ID
382-201-00032
Clinicaltrials.gov ID
NCT07759128
EudraCT ID
N/A
EUCTIS ID
2026-526033-25-00
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Recruiting
Sponsor ID
382-201-00032
Trial Details
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Age
18+ years
Therapeutic Area
  • Anxiety
    • Sex
    Female & Male
    Trial Dates
    Jul 2026 - Dec 2028
    Healthy Volunteers
    No
    • Male or female participants at least 18 years of age at the time of informed consent
    • Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
    • Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive)
    • Participant is willing and able to comply with study procedures and visit schedule
    • Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests
    • Willing and able to discontinue prohibited medications/therapies per protocol
    • i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions
    • Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.
    • Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
    • Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
    • Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
    • Significant suicide risk (e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \[C-SSRS\] or MADRS)
    • Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
    • Prior exposure to restricted treatments
    • Pregnant or breastfeeding females
    • Participation in another investigational study within 180 days (or more than \[\>\] 1 trial in last year)
    • Known history of human immunodeficiency virus seropositivity, hepatitis B or C

    Study Summary

    This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    Triple
    Estimated Enrollment
    576
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Male or female participants at least 18 years of age at the time of informed consent
    • 2. Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation

    Exclusion Criteria

    • 1. Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
    • 2. Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female participants at least 18 years of age at the time of informed consent
    • Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
    • Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive)
    • Participant is willing and able to comply with study procedures and visit schedule
    • Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests
    • Willing and able to discontinue prohibited medications/therapies per protocol
    • i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions
    • Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.
    Exclusion Criteria:
    • Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
    • Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
    • Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
    • Significant suicide risk (e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \[C-SSRS\] or MADRS)
    • Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
    • Prior exposure to restricted treatments
    • Pregnant or breastfeeding females
    • Participation in another investigational study within 180 days (or more than \[\>\] 1 trial in last year)
    • Known history of human immunodeficiency virus seropositivity, hepatitis B or C

    Locations

    Location
    Status
    Location
    Del Sol Research Management
    Tucson, Arizona, United States, 85715
    Status
    Recruiting
    Location
    Pharmacology Research Institute
    Encino, California, United States, 91316
    Status
    Recruiting
    Location
    California Neuroscience Research Medical Group, Inc
    Sherman Oaks, California, United States, 91403
    Status
    Recruiting
    Location
    Emerson Clinical Research Institute - Washington, DC
    Washington D.C., District of Columbia, United States, 20009
    Status
    Recruiting
    Location
    Sarkis Clinical Trials - Gainesville
    Gainesville, Florida, United States, 32607
    Status
    Recruiting
    Location
    Clinical Neuroscience Solutions, LLC
    Jacksonville, Florida, United States, 32256
    Status
    Recruiting
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