NCT06559306From ClinicalTrials.govRecruiting

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

Depressive Disorder, Major

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 752
Started: 25 July 2024
Main results due: 30 December 2026
Study sites: 205
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 74 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(205)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Completed
Chandler Clinical Trials
Chandler, Arizona, United States
Completed
University of Arizona
Tucson, Arizona, United States
Recruiting
SanRo Clinical Research Group LLC WCG Clinical Network
Bryant, Arkansas, United States
Recruiting
Preferred Research Partners
Little Rock, Arkansas, United States
Completed
PAMOJA Clinical Institute LLC
Anaheim, California, United States
Recruiting
Axiom Research
Colton, California, United States
Recruiting
Elite Research Network 6
Encino, California, United States
Completed
Behavioral Research Specialists LLC
Glendale, California, United States
Recruiting
WR PRI Los Alamitos
Los Alamitos, California, United States
Completed
Excell Research Inc
Oceanside, California, United States
Recruiting
Prospective Research Innovations Inc
Rancho Cucamonga, California, United States
Completed
Anderson Clinical Research
Redlands, California, United States
Recruiting
Lumos Clinical Research Center LLC
San Jose, California, United States
Recruiting
Syrentis Clinical Research
Santa Ana, California, United States
Completed
California Neuroscience Research
Sherman Oaks, California, United States
Completed
Mountain View Clinical Research
Denver, Colorado, United States
Recruiting
UConn Health Center
Farmington, Connecticut, United States
Recruiting
Clinical Research of Brandon
Brandon, Florida, United States
Recruiting
AGA Clinical Trials
Hialeah, Florida, United States
Recruiting
Reliable Clinical Research
Hialeah, Florida, United States
Recruiting
Advanced Research Institute of Miami
Homestead, Florida, United States
Recruiting
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, United States
Recruiting
Multi Specialty Research Associates Inc
Lake City, Florida, United States
Completed
Alcanza Clinical Research
Largo, Florida, United States
Completed
Pharmax Research Clinic Inc
Miami, Florida, United States
Recruiting
Miami Dade Medical Research Institute
Miami, Florida, United States
Recruiting
Nuovida Research Center
Miami, Florida, United States
Recruiting
Aqualane Clinical Research
Naples, Florida, United States
Completed
Bravo Health Care Center
North Bay Village, Florida, United States
Completed
Nova Psychiatry INC
Orlando, Florida, United States
Recruiting
Florida Center for TMS
Saint Augustine, Florida, United States
Completed
University of South Florida
Tampa, Florida, United States
Completed
Psych Me Medical Research Inc
Tampa, Florida, United States
Recruiting
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Recruiting
Conquest Research
Winter Park, Florida, United States
Completed
Advanced Discovery Research
Atlanta, Georgia, United States
Recruiting
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Recruiting
iResearch Atlanta LLC
Decatur, Georgia, United States
Recruiting
Peachford Hospital-Atlanta Behavorial Research
Dunwoody, Georgia, United States
Completed
iResearch Savannah
Savannah, Georgia, United States
Completed
Accelerated Clinical Research Group LLC
Snellville, Georgia, United States
Completed
Renew Health Clinical Research
Snellville, Georgia, United States
Completed
Northwestern University
Chicago, Illinois, United States
Recruiting
MetroMed Clinical Research
Chicago, Illinois, United States
Completed
University of Chicago Medical Center
Chicago, Illinois, United States
Completed
Revive Research Institute
Elgin, Illinois, United States
Completed
Baber Research Group
Naperville, Illinois, United States
Recruiting
Boston Clinical Trials
Boston, Massachusetts, United States
Completed
Adams Clinical LLC
Watertown, Massachusetts, United States
Recruiting
Mankato Clinic
Mankato, Minnesota, United States
Completed
Redbird Research
Las Vegas, Nevada, United States
Completed
Oasis Clinical Research LLC
Las Vegas, Nevada, United States
Completed
ActivMed Practices and Research
Portsmouth, New Hampshire, United States
Completed
Integrative Clinical Trials LLC
Brooklyn, New York, United States
Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Recruiting
University at Buffalo Psychiatry
Buffalo, New York, United States
Completed
Bioscience Research LLC
Mount Kisco, New York, United States
Recruiting
Fieve Clinical Research Inc
New York, New York, United States
Recruiting

Showing 60 of 205 sites — filter to narrow it down. 108 of the 205 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06559306. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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