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Seltorexant for Depression

Phase 1
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 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
Awards & highlights

Study Summary

This trial will test if Seltorexant is a safe and tolerable treatment for depression in adolescents when taken with an antidepressant.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,256 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,853 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an unprecedented clinical trial?

"Janssen Research & Development, LLC's Seltorexant is presently being trialled across 28 countries and 133 cities. This drug received its initial approval in 2020 as part of a Phase 1 trial which included 64 participants. Since then, 18341 studies have been concluded regarding this medication."

Answered by AI

Does this study permit participants under the age of fifty?

"To be eligible for this trial, subjects must fall between the age of 12 and 17. Across the nation, there are 192 clinical trials open to minors, while 968 studies exist that focus on seniors over 65 years old."

Answered by AI

What other investigations have been done to evaluate the efficacy of Seltorexant?

"In 2020, Seltorexant was initially trialed at Universitaetsklinikum der RWTH Aachen. To-date, 18341 studies have been concluded with 6 active trials taking place in The Woodlands, Texas."

Answered by AI

Is this research endeavor open to new participants at the present time?

"According to the information provided on clinicaltrials.gov, this medical trial is currently looking for patients. It was first posted in September 2021 and recently updated in November 2022."

Answered by AI

What is the ultimate purpose of this experiment?

"Janssen Research & Development, LLC., the sponsor of this clinical trial, has specified that it will be measuring and reporting on Treatment Emergent Adverse Events (TEAEs) over a period of up to 6 weeks as its primary outcome. Secondary outcomes include Change in Subjective Sleep Related Impairment (PROMIS-Pediatric-Sleep-Related Impairment [SRI]), measured using an 8 question Likert scale with higher scores indicating more sleep disturbance; Change from Baseline to Week 6/End of Treatment (EOT) in the Children's Depression Rating Scale (CDRS) Total Score; and change"

Answered by AI

Has Seltorexant attained official sanctioning from the FDA?

"As Seltorexant is only in its first phase of clinical trials, the safety rating assigned by our team was 1 due to the limited evidence collected thus far."

Answered by AI

How many individuals are actively engaged in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this study is actively enrolling participants; it was initially uploaded on September 2nd 2021 and underwent its last update November 9th 2022. The trial requires 52 recruits from 12 different medical centres."

Answered by AI

Who is eligible to be part of this research endeavor?

"This clinical trial is seeking 52 adolescents aged 12 to 17 who are suffering from involutional psychosis. To be eligible, participants must possess a Children's Depression Rating Scale-Revised (CDRS-R) score of at least 48 with no more than 25% improvement during screening; have responded inadequately (<50%) to one or two antidepressant treatments including fluoxetine and escitalopram after 6 weeks on the minimum therapeutic dose, 4 weeks on the optimal dose prior to screening; weigh between the fifth and ninety-fifth percentile for age and sex (with obese patients above 95th percentile OR underweight ones below 5th percentile"

Answered by AI

At what number of healthcare facilities is this trial currently taking place?

"This trial is presently enrolling participants from a dozen sites, which are situated in The Woodlands, Dallas and South Bend amongst other cities. To minimize commuting to the medical centre for check-ups, it would be best if you select a site close by when signing up."

Answered by AI

Who else is applying?

What site did they apply to?
Yale University
University of Texas Southwestern Medical Center
Other
Southwest Autism Research and Resource Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I don’t want others to suffer as I have.
PatientReceived 2+ prior treatments
~13 spots leftby Feb 2025