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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 Oct 17, 2026, 3:21 AM 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 31, 2023 (Actual)
Primary completion
Sep 23, 2024 (Actual)
Completion
Sep 23, 2024 (Actual)
Last update posted
Dec 11, 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.

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 11, 2025 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05741528 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →