A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant

Conditions

• Depressive Disorder, Major

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• Seltorexant — DRUG
  Seltorexant tablet will be administered orally once daily.
• Placebo — DRUG
  Matching placebo tablet will be administered orally once daily.

Study Details

The purpose of this study is to assess the efficacy of seltorexant compared with placebo as 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 an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.

Key Dates

Start date

Sep 16, 2020

Status verified

Apr 2026

Primary completion

Apr 25, 2023

Completion

Apr 30, 2024

Study Design

Enrollment

588 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Seltorexant
  Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (Up to 1 Year).
• Placebo Comparator: Placebo
  Participants will receive matching placebo tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.

Primary Outcome Measure

Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1 [ Time Frame: Baseline (Day 1), Day 43 ]

Locations (51)

Related coverage on Hipa.ai

• Seltorexant Phase 3 Trial Shows Improved Depression in MDD with Insomnia
  Seltorexant · May 12, 2026 · ClinicalTrials.gov
• Seltorexant Phase 3 for MDD with Insomnia Shows MADRS Score Improvement
  Seltorexant · Apr 25, 2023 · ClinicalTrials.gov

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