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Seltorexant for Depression

Phase 3
Recruiting
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
Must have a major depressive episode of at least moderate severity
Participants in part 1 and direct enrollers to part 2 must meet DSM-5 MDD without psychotic features diagnosed with first depressive episode prior to age 60
Must not have
Current signs/symptoms of hypothyroidism or hyperthyroidism
Taking thyroid supplementation for antidepressant purposes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)
Awards & highlights

Summary

"This trial aims to see how effective seltorexant is in treating depressive symptoms in people with major depressive disorder and insomnia. It will also assess the safety and maintenance of seltorexant

Who is the study for?
This trial is for adults and elderly with major depressive disorder (MDD) who also have insomnia symptoms. Participants must be currently taking an SSRI or SNRI but not fully responding to it.
What is being tested?
The study tests if adding Seltorexant to existing antidepressant therapy (SSRI/SNRI) is more effective than a placebo in improving depression and sleep in patients with MDDIS.
What are the potential side effects?
Possible side effects of Seltorexant include drowsiness, headache, dizziness, nausea, fatigue, dry mouth, and potential changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am experiencing a moderate to severe depressive episode.
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I was diagnosed with depression without psychosis before age 60.
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I've tried 1-2 antidepressants without enough improvement in my current depressive episode.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am experiencing symptoms of thyroid issues.
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I am taking thyroid medication to help with depression.
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I have a history of narcolepsy and seizures.
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I have a history of significant hormonal disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response
Secondary study objectives
Change From Baseline to Endpoint of the DB Maintenance Phase in the MADRS-6 score
Change from Baseline to Endpoint of the DB Maintenance Phase in the MADRS symptoms other than insomnia MADRS Without Sleep Item (MADRS-WOSI)
Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at Day 43
+12 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Open Label (OL) SeltorexantExperimental Treatment2 Interventions
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.
Group II: Part 2: DB SeltorexantExperimental Treatment2 Interventions
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Group III: Part 1: SeltorexantExperimental Treatment2 Interventions
Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.
Group IV: Part 1: PlaceboPlacebo Group2 Interventions
Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Group V: Part 2: DB PlaceboPlacebo Group2 Interventions
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
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
987 Previous Clinical Trials
6,384,907 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrailStudy DirectorJanssen Research & Development, LLC
1 Previous Clinical Trials
64 Total Patients Enrolled
~501 spots leftby Dec 2026
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