NCT07053345

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

An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Esketamine Nasal Spray in Korean Participants With Treatment-Resistant Depression(TRD)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
DRUG	Esketamine 56 mg	Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
DRUG	Esketamine 84 mg	Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.

Timeline

• Start date: 2025-06-09
• Primary completion: 2027-06-25
• Completion: 2027-06-25
• First posted: 2025-07-08
• Last updated: 2026-04-13

Locations

6 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study