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

NCT07053345 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd., Korea Clinical Trial · Janssen Korea, Ltd., Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2027-06-25
Completion
2027-06-25
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07053345 on ClinicalTrials.gov