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

Janssen Research & Development, LLC

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Brief 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).

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status
RECRUITING
phase
PHASE3
study type
INTERVENTIONAL
enrollment
348
sponsor
Janssen Research & Development, LLC
conditions
Depressive Disorder, Treatment-Resistant
interventions
DRUG: Esketamine 56 mg; DRUG: Esketamine 84 mg; DRUG: Placebo
start date
2026-07-23
start date type
ACTUAL
primary completion date
2028-12-27
has results
false
data source
ClinicalTrials.gov
data processed
2026-10-29T09:00:05
modifications
selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Record

Archive ID
nct:NCT07716098
Published
Jul 21, 2026
Updated
Sep 25, 2026
Venue
ClinicalTrials.gov
ClinicalTrials.gov
NCT07716098
Categories
Depressive Disorder, Treatment-Resistant
License
ClinicalTrials.gov terms (attribution, processing date, modifications noted)
Provenance
clinicaltrials

Topics