A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Public ClinicalTrials.gov record NCT06894212. 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 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Study identification
- NCT ID
- NCT06894212
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 538 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
- Feb 28, 2025 (Actual)
- Primary completion
- Oct 20, 2026 (Estimated)
- Completion
- Oct 29, 2026 (Estimated)
- Last update posted
- Oct 5, 2026
2025 – 2026
United States locations
- U.S. sites
- 35
- U.S. states
- 10
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pillar Clinical Research LLC - Bentonville Site | Bentonville | Arkansas | 72712 | — |
| Pillar Clinical Research (Little Rock AR) Site | Little Rock | Arkansas | 72204 | — |
| Woodland International Research Group Site | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest Site | Rogers | Arkansas | 72758 | — |
| Clinical Innovations, Inc. dba CITrials (Bellflower) | Bellflower | California | 90706 | — |
| ProScience Research Group Site | Culver City | California | 90230 | — |
| CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site | Garden Grove | California | 92845 | — |
| Synergy San Diego Site | Lemon Grove | California | 91945 | — |
| Catalina Research Institute Site | Montclair | California | 91763 | — |
| Clinical Innovations Inc. DBA CITrials (Riverside) | Riverside | California | 92506 | — |
| Richmond Behavioral Associates LLC | Riverside | California | 92506 | — |
| CNRI - San Diego LLC Site | San Diego | California | 92123 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| CenExel CNS - Los Alamitos (Collaborative Neuroscience Research) | Torrance | California | 90504 | — |
| Galiz Research Site | Hialeah | Florida | 33016 | — |
| Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site | Hollywood | Florida | 33021 | — |
| Cenexel RCA (Research Centers of America) Site | Hollywood | Florida | 33024 | — |
| Premier Clinical Research Institute | Miami | Florida | 33122 | — |
| D & H National Research Centers NC | Miami | Florida | 33155 | — |
| Innovative Clinical Research, Inc. Site | Miami Lakes | Florida | 33016 | — |
| Health Synergy Clinical Research LLC Site | West Palm Beach | Florida | 33407 | — |
| Synexus Clinical Research US Inc - Atlanta | Atlanta | Georgia | 30328 | — |
| CenExel ACMR (Atlanta Center for Medical Research, LLC) Site | Atlanta | Georgia | 30331 | — |
| CenExel IRA (CenExcel iResearch, LLC) Site | Decatur | Georgia | 30030 | — |
| Accelerated Clinical Trials in Peachtree Corners GA Site | Peachtree Corners | Georgia | 30071 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| Pillar Clinical Research LLC (Chicago) | Chicago | Illinois | 60641 | — |
| Eastern Clinical Research Associates | New Orleans | Louisiana | 70127 | — |
| Cenexel CBH (CBH Health) | Gaithersburg | Maryland | 20877 | — |
| Hassman Research Institute, LLC | Marlton | New Jersey | 20877 | — |
| Neuro-Behavioral Clinical Research Site | North Canton | Ohio | 44720 | — |
| Community Clinical Research Inc | Austin | Texas | 78754 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| HD Research - Memorial Hermann Surgery Center Memorial Village | Houston | Texas | 77043 | — |
| Pillar Clinical Research LLC (Richardson, TX) Site | Richardson | Texas | 75080 | — |
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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06894212, 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 5, 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 NCT06894212 live on ClinicalTrials.gov.