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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 25, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07716098). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 348 participants (ESTIMATED). Conditions: Depressive Disorder, Treatment-Resistant. Interventions: DRUG: Esketamine 56 mg; DRUG: Esketamine 84 mg; DRUG: Placebo. 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 , Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28). 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).