Seltorexant for Depression

Recruiting at 27 trial locations

Overseen By Study Contact

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Antidepressants

Disqualifiers: Liver, Renal, Cardiac, Psychiatric, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

31 Participants Needed

Trial Summary

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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.

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Seltorexant Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo tablets to seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6).

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires