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RecruitingPhase 3

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

NCT07716098 · Janssen Research & Development, LLC

Recruiting
Status
Accepting participants
Phase 3
Phase
348
Target enrolment
22
Study sites
5 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Double-Blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Day 1 to the End of the 4-Week Double-Blind Treatment Phase

    Measured over Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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)

Where

22 study sites

FacilityCityRegionCountry
Anderson Clinical ResearchRedlandsCaliforniaUnited States
Artemis Institute for Clinical ResearchSan DiegoCaliforniaUnited States
Psych Atlanta, P.C.MariettaGeorgiaUnited States
Psychiatric Medicine Associates LLCSkokieIllinoisUnited States
Neurobehavioral Research IncCedarhurstNew YorkUnited States
The Medical Research Network, LLCNew YorkNew YorkUnited States
Northwest Clinical Research CenterBellevueWashingtonUnited States
Kishiro Mental ClinicKawasaki-Japan
Tatsuta ClinicKobe-Japan
National Center of Neurology and PsychiatryKodaira-shi-Japan
Ichikawa ClinicMaebashi-Japan
The Jikei University HospitalMinatoku-Japan
Kyorin University HospitalMitaka-Japan
Arata ClinicNagasaki-Japan
Hokkaido University HospitalSapporo-Japan
Sangenjaya neurology-psychosomatic clinicSetagaya Ku-Japan
Maynds Tower Mental ClinicShibuya-ku-Japan
Tottori University HospitalTottori-Japan
Chung Shan Medical University HospitalTaichung-Taiwan
Taipei Medical UniversityTaipei-Taiwan
Taipei Veterans General HospitalTaipei-Taiwan
Linkou Chang Gung Memorial HospitalTaoyuan-Taiwan

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

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NCT07716098 on ClinicalTrials.gov →

Last updated in the registry 2026-09-25. Registry records change; this page reflects the data build of 2026-10-06.

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Where this trial sits