RecruitingPhase 4NCT07053345

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)


Sponsor

Janssen Korea, Ltd., Korea

Enrollment

47 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests esketamine nasal spray — a fast-acting treatment for severe depression — specifically in Korean patients whose depression has not improved with at least two different antidepressant medications. Esketamine works differently from traditional antidepressants and can start relieving symptoms within hours. **You may be eligible if...** - You are based in Korea and have been diagnosed with major depressive disorder - You have tried at least two antidepressants without adequate improvement (treatment-resistant depression) - You are 18 or older - You are currently taking an antidepressant and are willing to continue it alongside esketamine - You do not have active suicidal plans **You may NOT be eligible if...** - You have a history of psychosis, bipolar disorder type I, or certain other psychiatric conditions - You have a history of substance use disorder (especially alcohol, stimulants, or phencyclidine) - You have uncontrolled high blood pressure or serious heart or brain vessel disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEsketamine 56 mg

Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.

DRUGEsketamine 84 mg

Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.


Locations(6)

Cha Ilsan Medical Center

Goyang Si Gyeonggi Do, South Korea

Wonkwang University Hospital

Iksan, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Kyung Hee University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07053345


Related Trials