A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder

Study Identifier:
382-201-00034
ClinicalTrials.gov Identifier:
NCT07786454
EudraCT Identifier:
N/A
EU CT ID:
2026-526032-40-00
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-8522 or [email protected]
Will Be Recruiting
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Study Details

Medical Condition
  • Anxiety
Study Drug
  • Drug: SEP-363856
Date
Oct 2026 - May 2029
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
  • Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
  • Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
  • Participant is willing and able to comply with study procedures and visit schedule
  • 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
  • Key Exclusion Criteria
  • Diagnosis other than GAD that is the primary focus of treatment
  • Clinically significant psychiatric or medical condition that may interfere with study participation
  • Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
  • Clinically significant abnormal laboratory values or ECG findings
  • Significant suicide risk
  • Substance use/positive drug screen
  • Use of prohibited medications/therapies
  • Known sensitivity to SEP-363856

Protocol Summary

This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

Study Locations

No locations found.
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July 2025 01US25EUC0279

Requirements information
  • Key Inclusion Criteria
  • Male or female participants at least 18 years of age at the time of informed consent
  • Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
  • Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
  • Participant is willing and able to comply with study procedures and visit schedule
  • 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
  • Key Exclusion Criteria
  • Diagnosis other than GAD that is the primary focus of treatment
  • Clinically significant psychiatric or medical condition that may interfere with study participation
  • Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
  • Clinically significant abnormal laboratory values or ECG findings
  • Significant suicide risk
  • Substance use/positive drug screen
  • Use of prohibited medications/therapies
  • Known sensitivity to SEP-363856

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