Seltorexant for Depression

Recruiting at 82 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: SSRIs, SNRIs

Must not be taking: Thyroid supplements

Disqualifiers: Severe renal insufficiency, Cardiovascular, Diabetes, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

2 Power Preferred Clinics 2 of this trial's clinics are considered top 20 on Power

Compensation: Varies

Number of Visits: Unknown

752 Participants Needed

Trial Summary

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.

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.

Research Team

Janssen Research & Development, LLC Clinical Trail

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

Have you tried at least one antidepressant that has not helped your symptoms?

Are you currently taking Antidepressant medication?

Have you been diagnosed with Insomnia?

Exclusion Criteria

Do you have a history of narcolepsy or seizures?

Are you taking thyroid supplementation for antidepressant purposes

History of narcolepsy and seizures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive seltorexant or placebo orally once daily for 6 weeks during the double-blind treatment phase

6 weeks

Weekly visits (in-person)

Follow-up Part 1

Participants who do not proceed to Part 2 undergo a post-treatment follow-up phase

4 weeks

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

Variable

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

Up to 337 days

Follow-up Part 2

Participants are monitored for safety and effectiveness after the maintenance phase

4 weeks

Treatment Details

Interventions

• Seltorexant

Trial Overview The study tests if adding Seltorexant to existing antidepressant therapy (SSRI/SNRI) is more effective than a placebo in improving depression and sleep in patients with MDDIS.

Participant Groups

Group I: Part 2: Open Label (OL) Seltorexant Experimental Treatment 2 Interventions

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.

Group II: Part 2: DB Seltorexant Experimental Treatment 2 Interventions

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

Group III: Part 1: Seltorexant Experimental Treatment 2 Interventions

Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.

Group IV: Part 1: Placebo Placebo Group 2 Interventions

Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

Group V: Part 2: DB Placebo Placebo Group 2 Interventions

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

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