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Terminated Phase 3 Interventional

A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

ClinicalTrials.gov ID: NCT04109950

Public ClinicalTrials.gov record NCT04109950. 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 Jul 22, 2026, 6:42 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 Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia

Study identification

NCT ID
NCT04109950
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
463 participants

Conditions and interventions

Conditions

Interventions

  • SEP-363856 Drug

Drug

Eligibility (public fields only)

Age range
13 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 19, 2019
Primary completion
Nov 8, 2023
Completion
Nov 8, 2023
Last update posted
Dec 15, 2024

2019 – 2023

United States locations

U.S. sites
25
U.S. states
12
U.S. cities
22
Facility City State ZIP Site status
Research Site Little Rock Arkansas 72211
Research Site Rogers Arkansas 72758
Research Site Anaheim California 92805
Research Site Culver City California 90230
Research Site Lemon Grove California 91945
Research Site Long Beach California 90806
Research Site Long Beach California 90807
Research Site Montclair California 91763
Research Site San Diego California 92102
Research Site Sherman Oaks California 91403
Research Site Miami Springs Florida 33166
Research Site Oakland Park Florida 33334
Research Site Atlanta Georgia 30030
Research Site Atlanta Georgia 30318
Research Site Atlanta Georgia 30331
Research Site Decatur Georgia 30030
Research Site Lake Charles Louisiana 70629
Research Site Gaithersburg Maryland 20877
Research Site Flowood Mississippi 39232
Research Site St Louis Missouri 63125
Research Site Marlton New Jersey 08053
Research Site New York New York 10032
Research Site Dayton Ohio 45417
Research Site Austin Texas 78754
Research 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 53 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04109950, 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 15, 2024 · Synced Jul 22, 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 NCT04109950 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →