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

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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

Timeline

Start

2019-10-14

Primary completion

2023-06-14

Completion

2023-06-14

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs SEP-363856 100mg; p = 0.041; LS Mean Difference -3.8 (95% CI -7.5 to -0.1) NCT04092686 ↗

Drugs

Indications