What is the mechanism of action of this treatment?

Common treatments for Major Depressive Disorder (MDD) include selective serotonin reuptake inhibitors (SSRIs) and orexin receptor antagonists like Seltorexant. SSRIs increase serotonin levels in the brain by inhibiting its reuptake, thereby enhancing mood and emotional stability. Orexin receptor antagonists target the orexin system, which regulates arousal and wakefulness, helping to improve sleep and reduce anxiety. Understanding these mechanisms is important for MDD patients to select the most appropriate treatment based on their specific symptoms and treatment response.

What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder (MDD) include SSRIs, SNRIs, and TCAs. SSRIs, such as fluoxetine and sertraline, often cause nausea, insomnia, sexual dysfunction, and weight gain. SNRIs, like venlafaxine and duloxetine, can cause similar side effects along with increased blood pressure and heart rate. TCAs, such as amitriptyline, frequently result in sedation, dry mouth, constipation, and weight gain. Seltorexant, an orexin receptor antagonist currently under study, may cause daytime sleepiness and impairment. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Major Depressive Disorder (MDD), primarily focusing on antidepressants such as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs). These include medications like fluoxetine, sertraline, and venlafaxine. Additionally, other classes of drugs such as atypical antipsychotics (e.g., aripiprazole) have been approved as adjunctive therapies for MDD. While Seltorexant, an Orexin Receptor Antagonist, is being studied as an adjunctive therapy to SSRIs, similar orexin receptor antagonists like lemborexant and daridorexant have been approved for insomnia but not specifically for MDD.

What other types of research exist?

Promising novel alternatives to Seltorexant for Major Depressive Disorder patients include Lemborexant, particularly for those with comorbid insomnia, and triple reuptake inhibitors, which are being developed to target multiple neurotransmitters for potentially broader efficacy.

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Seltorexant for Depression

Phase 1

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

Must have Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to (>=) 48 at screening and >=40 at the baseline visit

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Summary

This trial is testing a new drug called Seltorexant to see if it can help teenagers with major depression who also have trouble sleeping. The drug is added to their usual antidepressants. It works by blocking a specific brain receptor that affects mood and sleep. The study will check if the drug is safe and well-tolerated. Seltorexant has shown potential in improving sleep and reducing depressive symptoms, particularly in patients with insomnia.

Who is the study for?

Adolescents with major depressive disorder who haven't improved after trying one or two SSRI antidepressants and psychotherapy can join this trial. They must have a certain level of depression severity, weigh between the fifth and ninety-fifth percentile for their age unless medically cleared, and girls able to have children need a negative pregnancy test.

What is being tested?

The study is testing Seltorexant as an additional treatment alongside an antidepressant compared to a placebo (a pill without active medication). The goal is to see if it's safe and helps improve symptoms in young people with depression more than just the antidepressant alone.

What are the potential side effects?

While not specified here, common side effects of adjunctive therapies like Seltorexant may include drowsiness, headache, nausea, dry mouth, increased appetite or weight changes. Each person might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

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

Select...

My depression score is high enough to meet the trial's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants with Abnormalities in Clinical Laboratory Values

Number of Participants with Abnormalities in Electrocardiogram (ECG)

Number of Participants with Abnormalities in Physical Examination

+7 more

Secondary study objectives

Change from Baseline in Clinical Global Impression- severity (CGI-S) Score Over Time

Change from Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Score

Change from Baseline to Week 6/EOT on Objective Sleep Assessment Actigraphy

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SeltorexantExperimental Treatment1 Intervention

Participants will receive weight based dose of Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6). Participants will continue baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (Fluoxetine or escitalopram) orally once daily.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo tablets to seltorexant 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

0 / 1Eligibility 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 selective serotonin reuptake inhibitors (SSRIs) and orexin receptor antagonists like Seltorexant. SSRIs increase serotonin levels in the brain by inhibiting its reuptake, thereby enhancing mood and emotional stability. Orexin receptor antagonists target the orexin system, which regulates arousal and wakefulness, helping to improve sleep and reduce anxiety. Understanding these mechanisms is important for MDD patients to select the most appropriate treatment based on their specific symptoms and treatment response.

Bulimia nervosa : a review of therapy research.