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Seltorexant for Depression
Study Summary
This trial will test if Seltorexant is a safe and tolerable treatment for depression in adolescents when taken with an antidepressant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a sleep disorder, but it's not severe like sleep apnea.I have received enough mental health support for my current depression.My weight is within the normal range for my age and sex, or I have medical clearance if not.I have a stable mental health condition but not major depression caused by it, or bipolar disorder.I have stable health conditions despite having a history of significant health issues.My depression hasn't improved much after trying 1 or 2 antidepressants, including fluoxetine or escitalopram.My depression score is high enough to meet the trial's requirements.I am a woman who can have children and have tested negative for pregnancy.You have a history of serious suicidal thoughts or actions within the past few months.
- Group 1: Seltorexant
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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"
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."
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."
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"
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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