Seltorexant for Depression
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Seltorexant or placebo as adjunctive therapy to antidepressants for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a telephone consult and on-site follow-up visit
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