MedTrace Logo

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

NCT04115319 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2025-12-31

Study results available
· View outcomes & findings →

Summary

A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia.

This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.

Conditions

Interventions

DRUG

SEP363856

SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule

DRUG

quetiapine XR

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-21
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Drug
Yes

Countries

  • United States
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115319 on ClinicalTrials.gov