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A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

Schizophrenia Clinical Trial

Official title:
An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents

Clinical Trial Summary

A clinical study that will evalute how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants, ages of 18 years to 65 years, with schizophrenia. The study will take place in approxmiately 24 study sites in North America. Particpants should expect to be in the study for up to 12 weeks.

Clinical Trial Description

This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study designed to evaluate the safety and tolerability, as well as effectiveness of switching clinically stable adult subjects with schizophrenia from a typical or atypical antipsychotic to SEP-363856. This study is projected to enroll approximately 120 subjects into a single treatment group (SEP-363856). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05628103
Study type Interventional
Source Sumitomo Pharma America, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 19, 2022
Completion date July 24, 2024
View Details
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