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A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy and an Open-labeled Long-term Safety Extension Treatment With Seltorexant

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Trial Profile

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy and an Open-labeled Long-term Safety Extension Treatment With Seltorexant

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 May 2026

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At a glance

  • Drugs Seltorexant (Primary)
  • Indications Insomnia; Major depressive disorder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Janssen Research & Development

Most Recent Events

  • 11 May 2026 According to an Johnson & Johnson media release, the data from the trial will be presented at the American Psychiatric Association (APA 2026) Annual Meeting and the American Society of Clinical Psychopharmacology (ASCP 2026) Annual Meeting.
  • 20 Jul 2024 This trial has been completed in Bulgaria (End Date: 30 Apr 2024), according to European Clinical Trials Database record.
  • 17 Jul 2024 Results presented on May 29, 2024 in a Johnson & Johnson Media Release.

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