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Clinical Trials in the USA / NCT06559306
Recruiting Phase 3

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

NCT06559306 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-07-25
Last updated
2026-08-28

Condition(s) studied

Depressive Disorder, Major

Investigational drug(s) / intervention(s)

SeltorexantPlaceboSelective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

Seltorexant: Seltorexant will be administered orally.

Placebo: Matching Placebo tablets will be administered orally.

Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI): SSRI/SNRI will be administered orally.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (205)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Completed
Chandler Clinical Trials Chandler Arizona Completed
University of Arizona Tucson Arizona Recruiting
SanRo Clinical Research Group LLC WCG Clinical Network Bryant Arkansas Recruiting
Preferred Research Partners Little Rock Arkansas Completed
PAMOJA Clinical Institute LLC Anaheim California Recruiting
Axiom Research Colton California Recruiting
Elite Research Network 6 Encino California Completed
Behavioral Research Specialists LLC Glendale California Recruiting
WR PRI Los Alamitos Los Alamitos California Completed
Excell Research Inc Oceanside California Recruiting
Prospective Research Innovations Inc Rancho Cucamonga California Completed
Anderson Clinical Research Redlands California Recruiting
Lumos Clinical Research Center LLC San Jose California Recruiting
Syrentis Clinical Research Santa Ana California Completed
California Neuroscience Research Sherman Oaks California Completed
Mountain View Clinical Research Denver Colorado Recruiting
UConn Health Center Farmington Connecticut Recruiting
Clinical Research of Brandon Brandon Florida Recruiting
AGA Clinical Trials Hialeah Florida Recruiting
Reliable Clinical Research Hialeah Florida Recruiting
Advanced Research Institute of Miami Homestead Florida Recruiting
Clinical NeuroScience Solutions Inc Jacksonville Florida Recruiting
Multi Specialty Research Associates Inc Lake City Florida Completed
Alcanza Clinical Research Largo Florida Completed
Pharmax Research Clinic Inc Miami Florida Recruiting
Miami Dade Medical Research Institute Miami Florida Recruiting
Nuovida Research Center Miami Florida Recruiting
Aqualane Clinical Research Naples Florida Completed
Bravo Health Care Center North Bay Village Florida Completed
Nova Psychiatry INC Orlando Florida Recruiting
Florida Center for TMS Saint Augustine Florida Completed
University of South Florida Tampa Florida Completed
Psych Me Medical Research Inc Tampa Florida Recruiting
Interventional Psychiatry of Tampa Bay Tampa Florida Recruiting
Health Synergy Clinical Research West Palm Beach Florida Recruiting
Conquest Research Winter Park Florida Completed
Advanced Discovery Research Atlanta Georgia Recruiting
Agile Clinical Research Trials, LLC Atlanta Georgia Recruiting
iResearch Atlanta LLC Decatur Georgia Recruiting

+ 165 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06559306 on ClinicalTrials.gov ↗ ← All trials in the USA