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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: 23 Jul 2024

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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

    • 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.
    • 17 Jul 2024 According to a Johnson & Johnson media release, findings from this study will be presented at this year's American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, which is being held from May 28-31 in Miami, Florida.
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