What is the mechanism of action of this treatment?

Common treatments for Major Depressive Disorder (MDD) include SSRIs, SNRIs, and Orexin Receptor Antagonists like Seltorexant. SSRIs increase serotonin levels, while SNRIs boost both serotonin and norepinephrine, aiding in mood regulation. Orexin Receptor Antagonists block orexin receptors, which can improve sleep and reduce depressive symptoms. Understanding these mechanisms helps in personalizing treatment, enhancing effectiveness, and minimizing side effects for MDD patients.

What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder (MDD) include SSRIs and SNRIs. SSRIs, such as citalopram, escitalopram, and sertraline, often cause side effects like nausea, insomnia, dizziness, dry mouth, and sexual dysfunction. SNRIs, such as venlafaxine and duloxetine, can cause similar side effects along with increased blood pressure and heart rate. Orexin receptor antagonists, like seltorexant, are being studied for their potential benefits in MDD with insomnia symptoms, and their side effects may include daytime sleepiness and next-day driving performance impairment. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Major Depressive Disorder (MDD), including selective serotonin reuptake inhibitors (SSRIs) like escitalopram, fluoxetine, and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine and venlafaxine. These medications have been shown to be effective in reducing depressive symptoms compared to placebo. While seltorexant, an orexin receptor antagonist, is currently being studied as an adjunctive therapy for MDD with insomnia symptoms, there is limited information on FDA-approved orexin receptor antagonists specifically for MDD. However, the ongoing research into seltorexant may provide new insights and potential future treatment options for patients with MDD.

What other types of research exist?

Lemborexant is a promising, novel alternative to Seltorexant for Major Depressive Disorder patients, particularly those with insomnia symptoms.

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Seltorexant for Depression

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

Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks, and for no greater than 18 months in the current episode

Participant must be medically stable on the basis of the following performed at screening: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and baseline

Must not have

Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode, as indicated by no or minimal (<25% improvement in symptoms) when treated with an antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 6 weeks)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Pivotal Trial

Summary

This trial is testing seltorexant, a new medication, to help people with depression and sleep problems who haven't improved enough with their current antidepressants. Seltorexant works by blocking a brain receptor to help improve sleep and mood.

Who is the study for?

Adults with major depressive disorder and insomnia who haven't improved enough on SSRIs or SNRIs can join. They must have a BMI of 18-40, stable health, no severe mental disorders like bipolar or psychosis, no serious sleep disorders other than insomnia, and not be at high risk for suicide.

What is being tested?

The trial is testing Seltorexant as an add-on to antidepressants against a placebo in people whose depression-related insomnia hasn't improved much with current treatments. It also looks at the long-term safety of Seltorexant.

What are the potential side effects?

Possible side effects aren't specified here but generally could include typical drug reactions such as nausea, headaches, dizziness, fatigue or more specific effects related to mood and sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've been taking a specific antidepressant without issues for 6 weeks to 18 months.

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My recent health checks, including heart tests, show I am medically stable.

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I have been diagnosed with depression without psychosis, first noticed before I was 60, and it has lasted no more than 24 months.

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My recent health checks, including heart tests, show I am medically stable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have depression that hasn't improved after trying 2 or more treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Double-blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

OL Treatment Phase: Change From Baseline in Blood Pressure

OL Treatment Phase: Change From Baseline in Body Mass Index (BMI)

+12 more

Secondary study objectives

DB Treatment Phase: Change From Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score

DB Treatment Phase: Change From Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score

DB Treatment Phase: Change From Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score

+7 more

Side effects data

From 2023 Phase 2 trial • 88 Patients • NCT05307692

Pancreatic Neuroendocrine Tumour

Pruritus

Malignant Biliary Obstruction

Orchitis

Neck Pain

Tension Headache

100%

80%

60%

40%

20%

Study treatment Arm

DB: Placebo

FU: Seltorexant

DB: Seltorexant

Follow-up (FU): Placebo

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SeltorexantExperimental Treatment1 Intervention

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).

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Seltorexant

2021

Completed Phase 3

~1700

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Major Depressive Disorder (MDD) include SSRIs, SNRIs, and Orexin Receptor Antagonists like Seltorexant. SSRIs increase serotonin levels, while SNRIs boost both serotonin and norepinephrine, aiding in mood regulation. Orexin Receptor Antagonists block orexin receptors, which can improve sleep and reduce depressive symptoms. Understanding these mechanisms helps in personalizing treatment, enhancing effectiveness, and minimizing side effects for MDD patients.