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Completed Phase 3 Interventional Results available

An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

ClinicalTrials.gov ID: NCT05741528

Public ClinicalTrials.gov record NCT05741528. 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, 1:21 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 Switched From Typical or Atypical Antipsychotic Agents

Brief summary

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

An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.

Study identification

NCT ID
NCT05741528
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
75 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
Mar 30, 2023
Primary completion
Sep 22, 2024
Completion
Sep 22, 2024
Last update posted
Dec 10, 2025

2023 – 2024

United States locations

U.S. sites
16
U.S. states
8
U.S. cities
15
Facility City State ZIP Site status
Research Site Anaheim California 92805
Research Site Bellflower California 90706
Research Site Garden Grove California 92845
Research Site Lemon Grove California 91945
Research Site Santee California 92071
Research Site Torrance California 90502
Research Site Hollywood Florida 33021
Research Site Miami Florida 33122
Research Site Atlanta Georgia 30318
Research Site Atlanta Georgia 30331
Research Site Chicago Illinois 60640
Research Site Gaithersburg Maryland 20877
Research Site Berlin New Jersey 08009
Research Site Charlotte North Carolina 28211
Research Site Hickory North Carolina 28601
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.

Recently updated Schizophrenia trials

Other public records listing Schizophrenia. Sorted by last update posted; newest first. Not a recommendation.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05741528, 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

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05741528 live on ClinicalTrials.gov.

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