New nasal spray could help those with stubborn depression
NCT ID NCT07053345
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study tests esketamine nasal spray in 47 Korean adults with treatment-resistant depression (depression that hasn't improved with other treatments). Participants will use the spray themselves twice a week for 4 weeks. The main goal is to see if depressive symptoms improve, measured by a standard depression scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- esketamine nasal spray
- What this could lead to
- If it works, this could offer a new option for people with depression that hasn't improved with other treatments.
- What could go wrong
- This is a small, early-phase study with only 47 participants, so results may not apply to everyone. Esketamine can cause side effects like dizziness, nausea, or dissociation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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47 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Must have a confirmed diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at the time of enrollment, without psychotic features, based on clinical assessment, and confirmed by mini international neuropsychiatric interview (MINI) * 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 \[\<=\] 25 percent \[%\] improvement of symptoms) to \>= 2 oral antidepressant treatments in the current moderate to severe episode of depression after having been given at an adequate dosage for an adequate duration of at least 6 weeks * At baseline (Day 1), the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current antidepressant (AD) treatment are still met (that is, nonresponse and minimal clinical improvement) * A female participant of childbearing potential must have a negative serum pregnancy test at screening and urine prior to the first dose of study intervention on Day 1 Exclusion Criteria: * 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 intervention or first data collection time point * Currently enrolled in an investigational study that involves treatments for MDD or may otherwise be expected to impact mood
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, 05505, South Korea
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Cha Ilsan Medical Center
Goyang Si Gyeonggi Do, 10414, South Korea
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Kangbuk Samsung Hospital
Seoul, 03181, South Korea
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Kyung Hee University Hospital
Seoul, 130 050, South Korea
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Samsung Medical Center
Seoul, 06351, South Korea
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Wonkwang University Hospital
Iksan, 570 711, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Brain-Signaling drug crack depression that resists standard treatment?
- One-Day brain zaps: a new hope for stubborn depression?
- Nasal spray could offer new hope for Treatment-Resistant depression
- Experimental depression drug aims to help when standard meds fail
- Laughing gas scans could unlock depression secrets
- Texts and brain zaps: new combo for tough depression?