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RecruitingPhase 3

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

Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT07767903

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
384
US sites recruiting
11
Study start
August 6, 2026
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: SEP-363856; Placebo

Conditions: Generalized Anxiety Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Anderson Clinical Research

    Redlands, CA 92374

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Clinical Neuroscience Solutions Inc. (CNS) - Orlando

    Orlando, FL 32801

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Adams Clinical - Watertown

    Watertown, MA 02472

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Lumina Clinical Research Center

    Cherry Hill, NJ 08002

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Basil Clinical

    Jamaica, NY 11413

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • IMA Clinical Research NYC Uptown

    New York, NY 10128

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Summit Research Network

    Portland, OR 97210

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Adams Clinical Philadelphia

    Philadelphia, PA 19104

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • CNS Healthcare - Memphis

    Memphis, TN 38112

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • DM Clinical Research - Bellaire

    Houston, TX 77081

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

  • Core Clinical Research

    Everett, WA 98201

    Site contact: Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com

Study contacts (from the official record)

  • Otsuka Call Center · 844-687-8522 · ProfessionalServices@otsuka-us.com
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A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856… (NCT07767903) | Bored Studies