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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

Pivotal Trial

Summary

This trial is testing seltorexant to see if it can help people with depression and insomnia who haven't improved with their current antidepressants. Seltorexant aims to improve mood and sleep by acting on certain brain receptors.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1700

0 / 7Eligibility criteria met