🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07716098
Recruiting Phase 3

A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression

NCT07716098 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2026-07-23
Last updated
2026-08-28

Condition(s) studied

Depressive Disorder, Treatment-Resistant

Investigational drug(s) / intervention(s)

Esketamine 56 mgEsketamine 84 mgPlacebo

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

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

Placebo: Participants will self-administer placebo as intranasal spray into each nostril.

Study summary

The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams \[mg\] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \[MDD\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participant must meet the diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single episode MDD, the duration of the episode must be greater than or equal to \[\>=\] 12 months) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the mini international neuropsychiatric interview (MINI) as the primary diagnosis. Participant must have had the first onset of depression prior to 55 years of age * Participant must have had nonresponse (less than or equal to \[\<=\] 25 percent \[%\] improvement) to \>=2 oral antidepressant treatments in the current episode of depression, assessed using the massachusetts general hospital-antidepressant treatment response questionnaire (MGH-ATRQ), and confirmed by documented records (for example, medical/pharmacy/prescription records or a letter from a treating physician) * The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the state versus trait, assessability, face validity, ecological validity, rule of three P's (SAFER) Interview * Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided * A female participant of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin \[β-hCG\]) at the start of screening and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1, prior to randomization Exclusion Criteria: * The participant has used ketamine/esketamine (lifetime) * The participant's depressive symptoms have demonstrated nonresponse in the current major depressive episode to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT, or to adequate course of treatment with transcranial magnetic stimulation (TMS), defined as at least 4 weeks of treatment with 5 sessions per week * Participant has received vagal nerve stimulation (VNS) or deep brain stimulation (DBS) in the current episode of depression * Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the columbia suicide severity rating scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past year prior to the start of the screening phase. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the double-blind treatment phase should be excluded * Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. a. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary * Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Anderson Clinical Research Redlands California Recruiting
Psychiatric Medicine Associates LLC Skokie Illinois Recruiting
The Medical Research Network, LLC New York New York Recruiting
Kishiro Mental Clinic Kawasaki Japan Recruiting
Tatsuta Clinic Kobe Japan Recruiting
National Center of Neurology and Psychiatry Kodaira-shi Japan Recruiting
Arata Clinic Nagasaki Japan Recruiting
Hokkaido University Hospital Sapporo Japan Recruiting
Sangenjaya neurology-psychosomatic clinic Setagaya Ku Japan Recruiting
Maynds Tower Mental Clinic Shibuya-ku Japan Recruiting
Tottori University Hospital Tottori Japan Recruiting
Chung Shan Medical University Hospital Taichung Taiwan Recruiting
Taipei Medical University Taipei Taiwan Recruiting
Taipei Veterans General Hospital Taipei Taiwan Recruiting
Linkou Chang Gung Memorial Hospital Taoyuan Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07716098 on ClinicalTrials.gov ↗ ← All trials in the USA