drugset / Trial / NCT04476446
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this expanded access program (EAP) is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with Treatment-Resistant Depression (TRD).
Timeline
- Start
- 2020-09-08
- Primary completion
- 2023-06-16
- Completion
- 2023-06-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | 56 mg | Intranasal |
| Subject | Esketamine | Other / unclassified | 84 mg | Intranasal |