Back to search results

Seltorexant for Major Depressive Disorder with Insomnia

This study is testing a drug called seltorexant to see if it helps adults and older adults (ages 18-74) with major depressive disorder (MDD) who also have trouble sleeping (insomnia symptoms). Participants in this study have not fully responded to their current antidepressant medicine (SSRI or SNRI). Researchers want to know how well seltorexant works, how safe it is, and if it helps keep depression symptoms from coming back. You would receive either seltorexant or a placebo (an inactive pill), along with your current antidepressant. The study aims to enroll 752 people. The study's current status is unclear, so it's not known if they are actively looking for participants.

Study design
This is an interventional study comparing seltorexant to a placebo, given along with an antidepressant. It plans to enroll 752 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants who respond well may be followed for up to 2 years and 10 months to see if their symptoms return.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06559306

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Recruiting
PHASE3Ages 18–74InterventionalTreatment
Janssen Research & Development, LLC
~752 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:SeltorexantPlaceboSelective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

At a glance

Recruiting sites
109 of 205 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
Measured over Baseline, Day 43
+1 more outcome measured

Conditions

Depressive Disorder, Major

Explore related trials

Unipolar Depression

Where it's being run

205 sites across 37 states
Florida19
Romania13
Brazil12
California11
Poland11
Texas10
Italy10
Turkey (Türkiye)10

Study leadership

  • Janssen Research & Development, LLC Clinical Trail · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60
Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment
Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks
Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening.
Must have completed Part 1 DB treatment phase
Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2
Was able to consistently follow the study procedures in Part 1 as judged by the investigator.
Must be medically stable based on clinical laboratory tests

Exclusion

Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
Has a history of narcolepsy and seizures
Has current signs/symptoms of hypothyroidism or hyperthyroidism
Participants taking thyroid supplementation for antidepressant purposes
Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis

What this trial measures

  • Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43Baseline, Day 43

    The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  • Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable ResponseTime from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)

    Stable response is defined as a greater than equal to (\>=) 50 percent (%) reduction in the MADRS total score for the last 3 consecutive visits of the OL stabilization Phase, as assessed by the site investigator. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve a stable response at the end of OL seltorexant treatment will be reported.