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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
Awards & highlights
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 belowSelect...
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
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 moreSecondary 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 moreTrial 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
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.
Bulimia nervosa : a review of therapy research.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,262 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,916 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Seltorexant
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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