A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
Public ClinicalTrials.gov record NCT05593029. 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, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS \& CGI-S) in MDD patients who had an inadequate response to prior ADT therapy.
Study identification
- NCT ID
- NCT05593029
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 929 participants
Conditions and interventions
Conditions
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
- Nov 9, 2022 (Actual)
- Primary completion
- Nov 6, 2025 (Actual)
- Completion
- Nov 13, 2025 (Actual)
- Last update posted
- Feb 18, 2026
2022 – 2025
United States locations
- U.S. sites
- 53
- U.S. states
- 22
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Scottsdale Clinical Research | Scottsdale | Arizona | 85260 | — |
| DelSol Research | Tucson | Arizona | 85715 | — |
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Wr-Pri, Llc | Encino | California | 91316 | — |
| Collaborative NeuroScience Research , LLC | Garden Grove | California | 92845 | — |
| Alliance Research | Long Beach | California | 90807 | — |
| ATP Clinical Research, Inc. | Orange | California | 92868 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| California Mental Behavioral Health | Santee | California | 92071 | — |
| Schuster Medical Research Institute SMRI | Sherman Oaks | California | 91403 | — |
| Viking Clinical Research | Temecula | California | 92591 | — |
| Collaborative Neuroscience Research LLC | Torrance | California | 90504 | — |
| Sunwise Clinical Research with is in Lafayette, CA | Walnut Creek | California | 94596 | — |
| Institute of Living Hartford Hospital | Hartford | Connecticut | 06106 | — |
| Clinical Neuroscience Solutions Inc. | Jacksonville | Florida | 32256 | — |
| K2 Medical Research | Maitland | Florida | 32751 | — |
| Central Miami Medical Institute | Miami | Florida | 33125 | — |
| Clinical Neuroscience Solutions Inc. dba CNS Healthcare | Orlando | Florida | 32801 | — |
| Combined Research Orlando Phase I-IV | Orlando | Florida | 32807 | — |
| K2 Medical Research | Tampa | Florida | 33607 | — |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | 33629 | — |
| Advanced Discovery Research LLC | Atlanta | Georgia | 30318 | — |
| Renew Health Clinical Research | Snellville | Georgia | 30078 | — |
| MetroMed Clinical Trials | Chicago | Illinois | 60614 | — |
| AMR Convention Research | Warrenville | Illinois | 60555 | — |
| Benchmark Research | Shreveport | Louisiana | 71101 | — |
| Cenexel CBH (CBH Health) | Gaithersburg | Maryland | 20877 | — |
| Copley Clinical | Boston | Massachusetts | 02116 | — |
| Boston Clinical Trials | Roslindale | Massachusetts | 02131 | — |
| Adams Clinical | Watertown | Massachusetts | 02471 | — |
| Vitalix Clinical | Worcester | Massachusetts | 01608 | — |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Integrative Clinical Trials | Brooklyn | New York | 11229 | — |
| Basil Clinical | Inwood | New York | 11096 | — |
| Berman Clinical | New York | New York | 10029 | — |
| Manhattan Behavioral Medicine PLLC | New York | New York | 10036 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| Patient Priority Clinical Studies LLC | Cincinnati | Ohio | 45215 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73116 | — |
| Suburban Research Associates | West Chester | Pennsylvania | 19380 | — |
| Clinical Neuroscience Solutions Inc. | Memphis | Tennessee | 38119 | — |
| Donald J. Garcia, Jr., MD, PA | Austin | Texas | 78737 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| FutureSearch Trials of Dallas | Dallas | Texas | 75251 | — |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | — |
| DM Clinical Research - Belliare | Houston | Texas | 77081 | — |
| Psychiatric And Behavioral Solutions, LLC | Millcreek | Utah | 84124 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
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 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05593029, 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 Feb 18, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05593029 live on ClinicalTrials.gov.