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Completed Phase 3 Interventional Results available

A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

ClinicalTrials.gov ID: NCT05628103

Public ClinicalTrials.gov record NCT05628103. 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.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 5:35 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

An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.

Study identification

NCT ID
NCT05628103
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
101 participants

Conditions and interventions

Conditions

Interventions

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
Dec 18, 2022
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update posted
Dec 10, 2025

2022 – 2024

United States locations

U.S. sites
25
U.S. states
11
U.S. cities
22
Facility City State ZIP Site status
Advanced Research Center, Inc. Anaheim California 92805
Clinical Innovations Inc. Bellflower California 90706
ProScience Research Group Culver City California 90230
Collaborative Neuroscience Research, LLC Garden Grove California 92845
Synergy San Diego Lemon Grove California 91945
Clinical Innovations, Inc Riverside California 92506
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) San Diego California 92102
CMB Clinical Trials Santee California 92071
Cenexel CNS Research Torrance California 90502
Larkin Behavioral Health Services Hollywood Florida 33021
Premier Clinical Research Institute, Inc. Miami Florida 33122
Wellness Research Center Miami Florida 33135
Nova Psychiatry, Inc. Orlando Florida 32803
Advanced Discovery Research LLC Atlanta Georgia 30318
Atlanta Center for Medical Research Atlanta Georgia 30331
Atlanta Behavioral Research Atlanta Georgia 30358
Uptown Research Chicago Illinois 60640
CBH Health Gaithersburg Maryland 20877
PsychCare Consultants Research St Louis Missouri 63128
IMA Clinical Research Las Vegas Nevada 89102
Hassman Research Institute Berlin New Jersey 08009
New Hope Clinical Research Charlotte North Carolina 28211
Clinical Trials of America, LLC Hickory North Carolina 28601
Charak Clinical Research Center Garfield Heights Ohio 44125
Pillar Clinical Research, LLC 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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05628103, 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 Dec 10, 2025 · Synced Sep 1, 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 protocol, eligibility criteria, and contact information for NCT05628103 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →