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Testing seltorexant for treating major depression with insomnia symptoms

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

PHASE3 · Janssen Research & Development, LLC · NCT06559306

This study is testing if adding a new medication called seltorexant can help adults and older people with major depression and insomnia feel better when their current antidepressants aren't enough.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment752 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorJanssen Research & Development, LLC (industry)
Locations205 sites (Birmingham, Alabama and 204 other locations)
Trial IDNCT06559306 on ClinicalTrials.gov

What this trial studies

This phase 3 study evaluates the effectiveness and safety of seltorexant as an additional treatment for adults and elderly patients suffering from major depressive disorder (MDD) with insomnia symptoms. Participants must have previously shown inadequate response to one or two antidepressants, specifically SSRIs or SNRIs. The study compares the effects of seltorexant against a placebo while participants continue their current antidepressant therapy. The goal is to determine if seltorexant can improve depressive symptoms and provide better management of insomnia.

Who should consider this trial

Good fit: Ideal candidates are adults and elderly individuals diagnosed with major depressive disorder who have not adequately responded to previous antidepressant treatments.

Not a fit: Patients who have not been diagnosed with major depressive disorder or those who have not tried any antidepressant medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with major depressive disorder and insomnia symptoms.

How similar studies have performed: Other studies have explored adjunctive treatments for depression, but the specific use of seltorexant in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants in part 1 and direct enrollers to part 2:

* 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.

Participants entering after completing part 1:

* 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 Criteria:

* 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

Where this trial is running

Birmingham, Alabama and 204 other locations

+155 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Depressive Disorder, Major

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.