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

Study Identifier:
382-201-00032
ClinicalTrials.gov Identifier:
NCT07759128
EudraCT Identifier:
N/A
EU CT ID:
2026-526033-25-00
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-8522 or [email protected]
Recruiting
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Study Details

Medical Condition
  • Anxiety
Study Drug
  • Drug: SEP-363856
Date
Jul 2026 - Dec 2028
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
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

Protocol 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.

Study Locations

Location
Status
Location
Clinical Neuroscience Solutions, LLC
Jacksonville, Florida, United States, 32256
Status
Recruiting
Location
Manhattan Behavioral Medicine PLLC
New York, New York, United States, 10036
Status
Recruiting
Location
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75251
Status
Recruiting
© 2025 Otsuka America Pharmaceutical, Inc.
All rights reserved.

July 2025 01US25EUC0279

Requirements information
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

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