drugset / Trial / NCT04115319
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |