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CompletedPhase 2/3

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

Key facts

Who runs it
Otsuka Pharmaceutical Development & Commercialization, Inc.
Where
Allentown, Atlanta, Austin, Boston, Brooklyn, Cedarhurst, Cherry Hill, Chicago, Culver City, Dallas, Draper, Huntsville, Jacksonville, Marlton, Mount Kisco, New York, North Canton, Oceanside, Oklahoma City, Orlando, Phoenix, Redlands, Saint Charles, Savannah, Sherman, Sherman Oaks, Tampa, Temecula, Torrance, Upland, Warrenville, and Watertown, United StatesSee the 38 sitesAlso in 7 other countries, 43 sites
Trial code
Status
Completed
Phase
Phase 2/3
People taking part
434 people enrolled
Started
8 Mar 2023
Ended
26 Sept 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • SEP-363856
  • Placebo
Record updated
10 October 2025

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • Female subject who is pregnant, lactating, or plans to get pregnant during the study

Where in United States

Also in 7 other countries, 43 sites

  • Lehigh Center for Clinical Research LLCAllentown, United States
  • Advanced Discovery Research, LlcAtlanta, United States
  • CenExel iResearch AtlantaAtlanta, United States
  • NeuroTrials Research IncAtlanta, United States
  • Psychiatry and Psychotherapy Partners AustinAustin, United States
  • Boston Clinical TrialsBoston, United States
  • Copley ClinicalBoston, United States
  • Social Psychiatry Research InstituteBrooklyn, United States
  • Neurobehavioral Research, Inc.Cedarhurst, United States
  • Center for Emotional Fitness SiteCherry Hill, United States
  • Uptown Research Institute, LLCChicago, United States
  • ProScience Research GroupCulver City, United States
  • FutureSearch Trials of Dallas, LPDallas, United States
  • Cedar Clinical Research Inc.Draper, United States
  • University of Alabama at BirminghamHuntsville, United States
  • CNS HealthcareJacksonville, United States
  • CenExel Hassman Research InstituteMarlton, United States
  • Bioscience Research LLCMount Kisco, United States
  • Berman ClinicalNew York, United States
  • Manhattan Behavioral MedicineNew York, United States
  • The Medical Research Network, L.L.CNew York, United States
  • Neuro-Behavioral Clinical Research Inc.North Canton, United States
  • Excell Research, Inc.Oceanside, United States
  • Paradigm Research Professionals, LLPOklahoma City, United States
  • Sooner Clinical ResearchOklahoma City, United States
  • Combined Research OrlandoOrlando, United States
  • IMA Clinical Research PhoenixPhoenix, United States
  • Anderson Clinical ResearchRedlands, United States
  • Midwest Research GroupSaint Charles, United States
  • Cenexel Iresearch - SavannahSavannah, United States
  • California Neuroscience Research, LLCSherman, United States
  • Schuster Medical Research InstituteSherman Oaks, United States
  • K2 Medical Research, LLCTampa, United States
  • Viking Pharmaceutical Trials Inc. dba Viking Clinical ResearchTemecula, United States
  • CenExel Collaborative Neuroscience ResearchTorrance, United States
  • Pacific Clinical Research Management GroupUpland, United States
  • American Medical Research, Inc.Warrenville, United States
  • Adams ClinicalWatertown, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • SEP-363856Treatment being tested

    dosed once daily tablet

  • PlaceboPlacebo, for comparison

    dosed once daily tablet

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder
Record updated
10 October 2025