Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Show 5 more changesShow less
    • Study completion pushed from Apr 15, 2027 to Dec 15, 2027
    • Interventions: Placebo (Drug), Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) (Drug), Seltorexant (Drug) to Placebo (Drug), Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) (Drug), Seltorexant (Drug)
    • Secondary endpoints: details revised at 15 of 15 entries
    • Site details revised at 9 of 205 sites
    • Eligibility criteria expanded, about 1 word
  2. Study completion pushed from Dec 30, 2026 to Apr 15, 2027
    • Site details revised at 17 of 205 sites
    v30
  3. Site details revised at 1 of 205 sitesv29
  4. Site details revised at 4 of 205 sitesv28
  5. Study sites revised (205)v27
  6. Site details revised at 7 of 205 sitesv26
  7. Trial sites expanded: 200 → 205 locationsv25
  8. Study sites: 198 to 200v24
  9. Study completion date: May 13, 2027 to Dec 30, 2026
    • Site details revised at 6 of 198 sites
    v23
  10. Re-verified, no change to tracked fieldsv22
  11. Study sites revised (198)v21
  12. Study sites: 196 to 198
    • Study completion date: Nov 30, 2027 to May 13, 2027
    v20
  13. Study sites: 195 to 196v19
  14. Study sites: 193 to 195v18
  15. Study sites: 190 to 193v17
  16. Study sites: 186 to 190v16
  17. Study sites: 174 to 186v15
  18. Study sites: 159 to 174v14
  19. Study sites: 127 to 159v13
  20. Study sites: 96 to 127v12
  21. Study sites: 91 to 96v11
  22. Study sites: 79 to 91v10
  23. Study sites: 73 to 79v9
  24. Study sites: 70 to 73v8
  25. Study sites: 63 to 70v7
  26. Re-verified, no change to tracked fieldsv6
  27. Study sites: 49 to 63v5
  28. Re-verified, no change to tracked fieldsv4
  29. Study sites: 21 to 49v3
  30. Study sites: 13 to 21
    • Study completion date: Jun 26, 2027 to Nov 30, 2027
    v2
  31. Study First Submitted
  • 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
289 trials monitored
See 16 trials at risk
Depression
3,072 trials monitored
See 174 trials at risk
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Trial Details
NCT Number NCT06559306
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Depressive Disorder, Major
Related terms Major Depressive Disorder
Enrollment 752 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov