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

Study Identifier:

SEP361-123

ClinicalTrials.gov Identifier:

NCT05463770

EudraCT Identifier:

N/A

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

N/A

Study Complete

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Study Details

Medical Condition

Schizophrenia

Study Drug

Drug: SEP-363856

Date

Aug 2022 - Aug 2023

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 18 - 65 Years

Requirements Information

Protocol Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes:

how the body processes (uses) glucose (blood sugar)
how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body.

The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose.

This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.

Study Locations

Location

Status

Location

Woodland International Research Group, LLC

Little Rock, Arkansas, United States, 72211

Status

N/A

Location

Woodland Research Northwest, LLC

Rogers, Arkansas, United States, 72758

Status

N/A

Location

Collaborative Neuroscience Research, LLC

Long Beach, California, United States, 90806

Status

N/A

Location

Catalina Research Institute LLC

Montclair, California, United States, 91763

Status

N/A

Location

CNRI - San Diego LLC

San Diego, California, United States, 92102

Status

N/A

Location

Galiz Research

Hialeah, Florida, United States, 33016

Status

N/A