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A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

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: 39 → 45 locations · Eligibility criteria expanded, about 61 words · Secondary endpoints: details revised at 12 of 12 entries Show 3 more changesShow less
    • Trial sites expanded: 39 → 45 locations
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 12 of 12 entries
  2. Trial sites expanded: 30 → 39 locationsv6
  3. Trial sites expanded: 16 → 30 locationsv5
  4. Trial sites expanded: 10 → 16 locationsv4
  5. Trial sites expanded: 5 → 10 locationsv3
  6. Recruitment opened Trial sites expanded: 0 → 5 locations · Start date changed from estimate of May 4, 2026 to Apr 30, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of May 4, 2026 to Apr 30, 2026
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.
Trial Details
NCT Number NCT07573176
Lead Sponsor Janssen Research & Development, LLC
Conditions Depressive Disorder, Major
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov