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Seltorexant for Major Depressive Disorder

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 43
Awards & highlights

Study Summary

This trial will compare Seltorexant against placebo as an addition to current antidepressant therapy in order to improve depressive symptoms in patients with MDDIS who have not responded well to SSRI or SNRI treatment.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 43 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 43
Secondary outcome measures
Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score to Day 43
Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score to Day 43
Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score to Day 43
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SeltorexantExperimental Treatment1 Intervention
Participants will receive Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6).
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo tablets orally once daily from Day 1 to Day 42 (until the end of Week 6).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seltorexant
2021
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,096 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,693 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
Florida
How old are they?
18 - 65
What site did they apply to?
Eastside Comprehensive Medical Services
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04532749.
~46 spots leftby Apr 2025
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