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Completed Phase 1 Interventional

A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

ClinicalTrials.gov ID: NCT05463770

Public ClinicalTrials.gov record NCT05463770. 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, 9:51 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, Fixed Sequence, Multiple Dose Study of Glucose and Insulin Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic Dysregulation

Study identification

NCT ID
NCT05463770
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
15 participants

Conditions and interventions

Conditions

Interventions

  • SEP-363856 Drug

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
Aug 29, 2022
Primary completion
Aug 21, 2023
Completion
Aug 21, 2023
Last update posted
Jun 25, 2024

2022 – 2023

United States locations

U.S. sites
8
U.S. states
5
U.S. cities
8
Facility City State ZIP Site status
Woodland International Research Group, LLC Little Rock Arkansas 72211
Woodland Research Northwest, LLC Rogers Arkansas 72758
Collaborative Neuroscience Research, LLC Long Beach California 90806
Catalina Research Institute LLC Montclair California 91763
CNRI - San Diego LLC San Diego California 92102
Galiz Research Hialeah Florida 33016
Neuro-Behavioral Clinical Research, Inc. North Canton Ohio 44720
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 NCT05463770, 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 Jun 25, 2024 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05463770 live on ClinicalTrials.gov.

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