Seltorexant for Major Depressive Disorder

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 3

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

Compensation: Varies

Number of Visits: Unknown

752 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Are You a Good Fit for This Trial?

Adults and elderly with major depressive disorder (MDD) who also have insomnia symptoms, and haven't fully responded to SSRI or SNRI antidepressants. Participants must be stable on their current antidepressant for a certain period before joining.

Inclusion Criteria

I was diagnosed with depression without psychosis before age 60.

I've tried 1-2 antidepressants without enough improvement.

Must be medically stable based on clinical laboratory tests

Exclusion Criteria

I do not have severe kidney problems or unstable health conditions.

History of narcolepsy and seizures

I am taking thyroid medication to help with depression.

What Are the Treatments Tested in This Trial?

Interventions

• Seltorexant

Trial Overview The trial is testing Seltorexant as an additional treatment alongside existing SSRI/SNRI therapy compared to a placebo. It aims to see if Seltorexant improves depression and sleep in those not fully helped by their current medication.

How Is the Trial Designed?

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.