drugset / Trial / NCT07053345

A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression

NCT07053345

Phase 4 Recruiting 47 enrolled Janssen Korea, Ltd., Korea
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate how well esketamine nasal spray works in improving depressive symptoms in participants with treatment resistant depression (TRD). This will be assessed by the change from baseline in the Hamilton depression rating scale (HAM-D; 17-item) total score from Day 1 (baseline) to the end of the 4-week treatment phase (Day 28).

Timeline

Start
2025-06-09
Primary completion
2027-06-25
Completion
2027-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 56 mg Intranasal
Subject Esketamine Other / unclassified 84 mg Intranasal