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Double-Blind, Randomized, Parallel-Group Study With Quetiapine Extended Release as Comparator 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

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Trial Profile

Double-Blind, Randomized, Parallel-Group Study With Quetiapine Extended Release as Comparator 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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2025

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At a glance

  • Drugs Seltorexant (Primary) ; Quetiapine
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 10 Oct 2025 According to Johnson and Johnson media release, data from this study will be presented at the annual European College of Neuropsychopharmacology (ECNP) Congress, taking place October 11-14 in Amsterdam, The Netherlands.
  • 15 Sep 2025 According to a Janssen media release, clinical data from this trial will be presented at the annual U.S. Psychiatric and Mental Health Congress (Psych Congress).
  • 05 Dec 2023 This trial has been completed in Czechia, according to European Clinical Trials Database record.

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