drugset / Trial / NCT04115319

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

NCT04115319 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-11-21
Primary completion
2022-12-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Quetiapine Small molecule 400 mg —
Comparator Quetiapine Small molecule 600 mg —
Comparator Quetiapine Small molecule 800 mg —
Subject Ulotaront Small molecule 50 mg —
Subject Ulotaront Small molecule 75 mg —
Subject Ulotaront Small molecule 100 mg —

Indications