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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 Therapy

NCT04532749 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-06-04

Study results available
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Summary

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 a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Seltorexant

Participants will receive Seltorexant tablets.

DRUG

Placebo

Participants will receive matching placebo tablets.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2022-05-24
Completion
2022-07-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Chile
  • Denmark
  • Finland
  • Malaysia
  • Poland
  • Slovakia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532749 on ClinicalTrials.gov