A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Study Identifier:

SEP361-301

ClinicalTrials.gov Identifier:

NCT04072354

EudraCT Identifier:

2019-000470-36

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 50mg
Drug: SEP-363856 75mg
Drug: Placebo

Date

Sep 2019 - May 2023

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 13 - 65 Years

Requirements Information

Protocol Summary

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.

Study Locations

Location

Status

Location

Woodland International Research Group, LLC

Little Rock, Arkansas, United States, 72211

Status

N/A

Location

Advanced Research Center, Inc.

Anaheim, California, United States, 92805

Status

N/A

Location

CITrials

Bellflower, California, United States, 90706

Status

N/A

Location

Synergy San Diego

Lemon Grove, California, United States, 91945

Status

N/A

Location

Alliance for Research

Long Beach, California, United States, 90807

Status

N/A

Location

Catalina Research Institute

Montclair, California, United States, 91763

Status

N/A