A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

Study Identifier:
SEP361-226
ClinicalTrials.gov Identifier:
NCT05729373
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Active, Not Recruiting
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Study Details

Medical Condition
  • Anxiety
Study Drug
  • Drug: SEP-363856
  • Drug: Placebo
Date
Mar 2023 - Sep 2025
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Inclusion Criteria: (list is not all inclusive)
  • Male or female subject between 18 to 65 years of age.
  • Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
  • Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.
  • Exclusion Criteria: (list is not all inclusive)
  • Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
  • Subjects who report an inadequate response to more than 3 antidepressant treatments
  • Subject is at significant risk of harming self or others based on Investigator's judgment.
  • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
  • Female subject who is pregnant, lactating, or plans to get pregnant during the study.

Protocol Summary

A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.

Study Locations

Location
Status
Location
University of Alabama at Birmingham
Huntsville, Alabama, United States, 35801
Status
N/A
Location
IMA Clinical Research Phoenix
Phoenix, Arizona, United States, 85012
Status
N/A
Location
ProScience Research Group
Culver City, California, United States, 90230
Status
N/A
Location
Excell Research, Inc.
Oceanside, California, United States, 92056
Status
N/A
Location
Anderson Clinical Research
Redlands, California, United States, 92374
Status
N/A
Location
California Neuroscience Research, LLC
Sherman, California, United States, 91403
Status
N/A
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© 2025 Otsuka America Pharmaceutical, Inc.
All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Inclusion Criteria: (list is not all inclusive)
  • Male or female subject between 18 to 65 years of age.
  • Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
  • Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.
  • Exclusion Criteria: (list is not all inclusive)
  • Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
  • Subjects who report an inadequate response to more than 3 antidepressant treatments
  • Subject is at significant risk of harming self or others based on Investigator's judgment.
  • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
  • Female subject who is pregnant, lactating, or plans to get pregnant during the study.

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