A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder
Public ClinicalTrials.gov record NCT05729373. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT05729373
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 434 participants
Conditions and interventions
Conditions
Interventions
- SEP-363856 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 7, 2023
- Primary completion
- Sep 25, 2025
- Completion
- Sep 25, 2025
- Last update posted
- Oct 9, 2025
2023 – 2025
United States locations
- U.S. sites
- 38
- U.S. states
- 15
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Huntsville | Alabama | 35801 | — |
| IMA Clinical Research Phoenix | Phoenix | Arizona | 85012 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Excell Research, Inc. | Oceanside | California | 92056 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| California Neuroscience Research, LLC | Sherman | California | 91403 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| Viking Pharmaceutical Trials Inc. dba Viking Clinical Research | Temecula | California | 92591 | — |
| CenExel Collaborative Neuroscience Research | Torrance | California | 90502 | — |
| Pacific Clinical Research Management Group | Upland | California | 91786 | — |
| CNS Healthcare | Jacksonville | Florida | 32256 | — |
| Combined Research Orlando | Orlando | Florida | 32803 | — |
| K2 Medical Research, LLC | Tampa | Florida | 33607 | — |
| CenExel iResearch Atlanta | Atlanta | Georgia | 30030 | — |
| Advanced Discovery Research LLC | Atlanta | Georgia | 30318 | — |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30328 | — |
| CenExel iResearch Savannah | Savannah | Georgia | 31405 | — |
| Uptown Research Institute, LLC | Chicago | Illinois | 60640 | — |
| American Medical Research, Inc. | Warrenville | Illinois | 60555 | — |
| Copley Clinical | Boston | Massachusetts | 02116 | — |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Center for Emotional Fitness Site | Cherry Hill | New Jersey | 08002 | — |
| CenExel Hassman Research Institute | Marlton | New Jersey | 08053 | — |
| Social Psychiatry Research Institute | Brooklyn | New York | 11235 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| Bioscience Research, LLC | Mount Kisco | New York | 10016 | — |
| Berman Clinical | New York | New York | 10029 | — |
| Manhattan Behavioral Medicine | New York | New York | 10036 | — |
| The Medical Research Network, L.L.C | New York | New York | 10128 | — |
| Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio | 44720 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Paradigm Research Professionals, LLP | Oklahoma City | Oklahoma | 73116 | — |
| Lehigh Center for Clinical Research, LLC | Allentown | Pennsylvania | 18104 | — |
| Psychiatry and Psychotherapy Partners Austin | Austin | Texas | 78737 | — |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | — |
| Cedar Clinical Research, Inc. | Draper | Utah | 84020 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05729373, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2025 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05729373 live on ClinicalTrials.gov.