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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Trial sites expanded: 15 → 22 locations · Secondary endpoints: details revised at 21 of 21 entries · Eligibility criteria expanded, about 5 words Show 3 more changesShow less
    • Trial sites expanded: 15 → 22 locations
    • Secondary endpoints: details revised at 21 of 21 entries
    • Eligibility criteria expanded, about 5 words
  2. Trial sites expanded: 4 → 15 locations Start date changed from estimate of Jul 27, 2026 to Jul 23, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Jul 27, 2026 to Jul 23, 2026
  3. Recruitment opened Trial sites expanded: 1 → 4 locations · Start date: Aug 3, 2026 to Jul 27, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 1 → 4 locations
    • Start date: Aug 3, 2026 to Jul 27, 2026
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Johnson & Johnson
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Depression
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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).
Trial Details
NCT Number NCT07716098
Lead Sponsor Janssen Research & Development, LLC
Conditions Depressive Disorder, Treatment-Resistant
Enrollment 348 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov