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

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT06894212
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SEP-363856 — DRUG
    tablet
  • Placebo — OTHER
    tablet

Study Details

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Key Dates

Start date
Feb 28, 2025
Status verified
May 2026
Primary completion
Oct 20, 2026
Completion
Oct 29, 2026

Study Design

Enrollment
522 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo
  • Experimental: SEP-363856 75 mg
    SEP-363856 75 mg/day
  • Experimental: SEP-363856 100 mg
    SEP-363856 100 mg/day

Primary Outcome Measure

The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6 [ Time Frame: Baseline to Week 6 ]

Central Contacts

Locations (35)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research LLC - Bentonville SiteBentonvilleArkansas72712-
Pillar Clinical Research (Little Rock AR) SiteLittle RockArkansas72204
Otsuka Call Center
Woodland International Research Group SiteLittle RockArkansas72211
Otsuka Call Center
Woodland Research Northwest SiteRogersArkansas72758
Otsuka Call Center
Clinical Innovations, Inc. dba CITrials (Bellflower)BellflowerCalifornia90706
Otsuka Call Center
ProScience Research Group SiteCulver CityCalifornia90230-
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) SiteGarden GroveCalifornia92845-
Synergy San Diego SiteLemon GroveCalifornia91945-
Catalina Research Institute SiteMontclairCalifornia91763-
Clinical Innovations Inc. DBA CITrials (Riverside)RiversideCalifornia92506-
Richmond Behavioral Associates LLCRiversideCalifornia92506-
CNRI - San Diego LLC SiteSan DiegoCalifornia92123-
Schuster Medical Research InstituteSherman OaksCalifornia91403
Otsuka Call Center
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)TorranceCalifornia90504-
Galiz Research SiteHialeahFlorida33016-
Cenexel RCA (Research Centers of America) SiteHollywoodFlorida33024-
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase SiteHollywoodFlorida33021-
D & H National Research Centers NCMiamiFlorida33155-
Premier Clinical Research InstituteMiamiFlorida33122-
Innovative Clinical Research, Inc. SiteMiami LakesFlorida33016
Otsuka Call Center
Health Synergy Clinical Research LLC SiteWest Palm BeachFlorida33407-
CenExel ACMR (Atlanta Center for Medical Research, LLC) SiteAtlantaGeorgia30331
Otsuka Call Center
Synexus Clinical Research US Inc - AtlantaAtlantaGeorgia30328
Otsuka Call Center
CenExel IRA (CenExcel iResearch, LLC) SiteDecaturGeorgia30030-
Accelerated Clinical Trials in Peachtree Corners GA SitePeachtree CornersGeorgia30071
Otsuka Call Center
Pillar Clinical Research LLC (Chicago)ChicagoIllinois60641-
Uptown Research InstituteChicagoIllinois60640
Otsuka Call Center
Eastern Clinical Research AssociatesNew OrleansLouisiana70127-
Cenexel CBH (CBH Health)GaithersburgMaryland20877-
Hassman Research Institute, LLCMarltonNew Jersey20877
Otsuka Call Center
Neuro-Behavioral Clinical Research SiteCantonOhio44720-
Community Clinical Research IncAustinTexas78754
Otsuka Call Center
InSite Clinical ResearchDeSotoTexas75115-
HD Research - Memorial Hermann Surgery Center Memorial VillageHoustonTexas77043-
Pillar Clinical Research LLC (Richardson, TX) SiteRichardsonTexas75080
Otsuka Call Center

Find similar trials in Bentonville, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Pillar Clinical Research LLC - Bentonville Site· Bentonville, ARPillar Clinical Research (Little Rock AR) Site· Little Rock, ARWoodland International Research Group Site· Little Rock, ARWoodland Research Northwest Site· Rogers, ARClinical Innovations, Inc. dba CITrials (Bellflower)· Bellflower, CAProScience Research Group Site· Culver City, CA

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