Seltorexant for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing seltorexant to see if it can help people with depression and insomnia who haven't improved with their current antidepressants. Seltorexant aims to improve mood and sleep by acting on certain brain receptors.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. The trial is designed to test seltorexant as an additional treatment alongside your existing antidepressant medication.
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trail
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults and elderly with major depressive disorder (MDD) who also have insomnia symptoms. Participants must be currently taking an SSRI or SNRI but not fully responding to it.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive seltorexant or placebo orally once daily for 6 weeks during the double-blind treatment phase
Follow-up Part 1
Participants who do not proceed to Part 2 undergo a post-treatment follow-up phase
Open Label Phase Part 2
Participants receive seltorexant orally in addition to their background SSRI/SNRI treatment during the open-label induction and stabilization phases
Double-Blind Maintenance Phase Part 2
Participants who achieve a stable response during the open-label phase receive seltorexant or placebo during the double-blind maintenance phase
Follow-up Part 2
Participants are monitored for safety and effectiveness after the maintenance phase
What Are the Treatments Tested in This Trial?
Interventions
- Seltorexant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University