A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

ClinicalTrials.gov ID: NCT06894212

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.

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ClinicalTrials.gov public records Last synced May 19, 2026, 8:53 PM EDT

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

Study identification

NCT ID: NCT06894212
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 522 participants

Conditions and interventions

Conditions

Schizophrenia

Interventions

Placebo Other
SEP-363856 Drug

Other · 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: Feb 27, 2025
Primary completion: Oct 19, 2026
Completion: Oct 28, 2026
Last update posted: May 13, 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	Active, not recruiting
Pillar Clinical Research (Little Rock AR) Site	Little Rock	Arkansas	72204	Recruiting
Woodland International Research Group Site	Little Rock	Arkansas	72211	Recruiting
Woodland Research Northwest Site	Rogers	Arkansas	72758	Recruiting
Clinical Innovations, Inc. dba CITrials (Bellflower)	Bellflower	California	90706	Recruiting
ProScience Research Group Site	Culver City	California	90230	Active, not recruiting
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site	Garden Grove	California	92845	Active, not recruiting
Synergy San Diego Site	Lemon Grove	California	91945	Withdrawn
Catalina Research Institute Site	Montclair	California	91763	Active, not recruiting
Clinical Innovations Inc. DBA CITrials (Riverside)	Riverside	California	92506	Completed
Richmond Behavioral Associates LLC	Riverside	California	92506	Active, not recruiting
CNRI - San Diego LLC Site	San Diego	California	92123	Active, not recruiting
Schuster Medical Research Institute	Sherman Oaks	California	91403	Recruiting
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)	Torrance	California	90504	Active, not recruiting
Galiz Research Site	Hialeah	Florida	33016	Active, not recruiting
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site	Hollywood	Florida	33021	Active, not recruiting
Cenexel RCA (Research Centers of America) Site	Hollywood	Florida	33024	Active, not recruiting
Premier Clinical Research Institute	Miami	Florida	33122	Active, not recruiting
D & H National Research Centers NC	Miami	Florida	33155	Active, not recruiting
Innovative Clinical Research, Inc. Site	Miami Lakes	Florida	33016	Recruiting
Health Synergy Clinical Research LLC Site	West Palm Beach	Florida	33407	Active, not recruiting
Synexus Clinical Research US Inc - Atlanta	Atlanta	Georgia	30328	Recruiting
CenExel ACMR (Atlanta Center for Medical Research, LLC) Site	Atlanta	Georgia	30331	Recruiting
CenExel IRA (CenExcel iResearch, LLC) Site	Decatur	Georgia	30030	Active, not recruiting
Accelerated Clinical Trials in Peachtree Corners GA Site	Peachtree Corners	Georgia	30071	Recruiting
Uptown Research Institute	Chicago	Illinois	60640	Recruiting
Pillar Clinical Research LLC (Chicago)	Chicago	Illinois	60641	Active, not recruiting
Eastern Clinical Research Associates	New Orleans	Louisiana	70127	Active, not recruiting
Cenexel CBH (CBH Health)	Gaithersburg	Maryland	20877	Active, not recruiting
Hassman Research Institute, LLC	Marlton	New Jersey	20877	Recruiting
Neuro-Behavioral Clinical Research Site	Canton	Ohio	44720	Active, not recruiting
Community Clinical Research Inc	Austin	Texas	78754	Recruiting
InSite Clinical Research	DeSoto	Texas	75115	Active, not recruiting
HD Research - Memorial Hermann Surgery Center Memorial Village	Houston	Texas	77043	Active, not recruiting
Pillar Clinical Research LLC (Richardson, TX) Site	Richardson	Texas	75080	Recruiting

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 May 13, 2026 · Synced May 19, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06894212 live on ClinicalTrials.gov.

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