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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 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

Side effects data

From 2023 Phase 2 trial • 88 Patients • NCT05307692
3%
Malignant Biliary Obstruction
3%
Pancreatic Neuroendocrine Tumour
3%
Orchitis
3%
Neck Pain
3%
Tension Headache
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB: Placebo
FU: Seltorexant
DB: Seltorexant
Follow-up (FU): Placebo

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
~1700

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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,872 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,899 Total Patients Enrolled

Media Library

Seltorexant Clinical Trial Eligibility Overview. Trial Name: NCT04951609 — Phase 1
Major Depressive Disorder Research Study Groups: Seltorexant, Placebo
Major Depressive Disorder Clinical Trial 2023: Seltorexant Highlights & Side Effects. Trial Name: NCT04951609 — Phase 1
Seltorexant 2023 Treatment Timeline for Medical Study. Trial Name: NCT04951609 — Phase 1
~7 spots leftby Dec 2025