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

Sponsor ID
382-201-00033
Clinicaltrials.gov ID
NCT07767903
EudraCT ID
N/A
EUCTIS ID
2026-526034-10-00
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Recruiting
Sponsor ID
382-201-00033
Trial Details
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Age
18+ years
Therapeutic Area
  • Anxiety
    • Sex
    Female & Male
    Trial Dates
    Aug 2026 - Oct 2028
    Healthy Volunteers
    No
    • Key Inclusion Criteria
    • Male or female participants at least 18 years of age at the time of informed consent
    • Primary diagnosis of 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) 18-40 kilograms per square meter (kg/m\^2)
    • 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 and able to comply with study procedures
    • 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
    • Willing and able to discontinue prohibited medications/therapies per protocol
    • Key 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

    Study Summary

    This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    Triple
    Estimated Enrollment
    384
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Key Inclusion Criteria
    • 1. Male or female participants at least 18 years of age at the time of informed consent

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Key Inclusion Criteria
    • Male or female participants at least 18 years of age at the time of informed consent
    • Primary diagnosis of 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) 18-40 kilograms per square meter (kg/m\^2)
    • 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 and able to comply with study procedures
    • 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
    • Willing and able to discontinue prohibited medications/therapies per protocol
    • Key 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
    Anderson Clinical Research
    Redlands, California, United States, 92374
    Status
    Recruiting
    Location
    Clinical Neuroscience Solutions Inc. (CNS) - Orlando
    Orlando, Florida, United States, 32801
    Status
    Recruiting
    Location
    Lumina Clinical Research Center
    Cherry Hill, New Jersey, United States, 08002
    Status
    Recruiting
    Location
    Basil Clinical
    Jamaica, New York, United States, 11413
    Status
    Recruiting
    Location
    Core Clinical Research
    Everett, Washington, United States, 98201
    Status
    Recruiting

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    January 2026 01US25EUC0489

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