31 Participants Needed

Seltorexant for Depression

Recruiting at 27 trial locations
SC
Overseen ByStudy Contact
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC
Must be taking: Antidepressants
Stay on Your Current MedsYou can continue your current medications while participating

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must have an inadequate response to their current antidepressant, either fluoxetine or escitalopram, to be eligible. This suggests you may continue taking your current antidepressant during the trial.

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.
My depression hasn't improved much after trying 1 or 2 antidepressants, including fluoxetine or escitalopram.
See 2 more

Exclusion Criteria

I have a sleep disorder, but it's not severe like sleep apnea.
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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive Seltorexant or placebo as adjunctive therapy to antidepressants for 6 weeks

6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a telephone consult and on-site follow-up visit

2 weeks
1 visit (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Seltorexant
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SeltorexantExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

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