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

Study Identifier:
382-201-00033
ClinicalTrials.gov Identifier:
NCT07767903
EudraCT Identifier:
N/A
EU CT ID:
2026-526034-10-00
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
  • Drug: Placebo
Date
Aug 2026 - Oct 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
  • 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

Protocol 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).

Study Locations

No locations found.
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All rights reserved.

July 2025 01US25EUC0279

Requirements information
  • 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

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