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New treatment option for Depressive Disorder, Treatment-Resistant
Official title A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
ClinicalTrials.gov ID: NCT07053345
What this study is testing
What is Esketamine 56 mg?
Esketamine 56 mg is an investigational medicine, being studied as a potential treatment for depressive disorder, treatment-resistant.
Also referred to as JNJ-54135419.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Must have a confirmed diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth...
- Must have a Hamilton depression rating scale (HAM-D; 17-item) total score greater than or equal to (\>=) 22 at screening and Day 1
- Participants must have had non-response (less than or equal to [\ = 2 oral antidepressant treatments in the current moderate to severe episode of...
- At baseline (Day 1), the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and...
- A female participant of childbearing potential must have a negative serum pregnancy test at screening and urine prior to the first dose of study...
You likely can't join if
- Participants with hyperthyroidism that has not been sufficiently treated
- History of malignancy within 5 years of enrollment before screening
- Known allergies, hypersensitivity, or intolerance to esketamine/ketamine or its excipients
- Received an investigational intervention or used an invasive investigational medical device within 60 days before the planned first dose of study...
- Currently enrolled in an investigational study that involves treatments for MDD or may otherwise be expected to impact mood
The study team makes the final eligibility decision.
Where it's taking place
- Goyang Si Gyeonggi Do, South Korea
- Iksan, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goyang Si Gyeonggi Do, South Korea; Iksan, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.