Recruiting
A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression
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).
ClinicalTrials.gov IDNCT07716098
PhasePHASE3
Enrollment348
SponsorJanssen Research & Development, LLC
Age18 Years
SexALL
Conditions studied
Depressive Disorder, Treatment-Resistant
About this study
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).
Interventions
- Drug: Esketamine 56 mg — Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
- Drug: Esketamine 84 mg — Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
- Drug: Placebo — Participants will self-administer placebo as intranasal spray into each nostril.
Primary outcomes
- 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 (Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28))
Eligibility information
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)
Study locations
- Anderson Clinical Research, Redlands, California 92374 United States
- Artemis Institute for Clinical Research, San Diego, California 92123 United States
- Psych Atlanta, P.C., Marietta, Georgia 30060 United States
- Psychiatric Medicine Associates LLC, Skokie, Illinois 60076 United States
- Neurobehavioral Research Inc, Cedarhurst, New York 11516 United States
- The Medical Research Network, LLC, New York, New York 10128 United States
- Northwest Clinical Research Center, Bellevue, Washington 98007 United States
- Kishiro Mental Clinic, Kawasaki, 214-0014 Japan
- Tatsuta Clinic, Kobe, 651-0097 Japan
- National Center of Neurology and Psychiatry, Kodaira-shi, 187-8551 Japan
Showing 10 of 22 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.