Tests seltorexant added to antidepressants for depression with insomnia
Tests seltorexant added to antidepressants in adults with depression and insomnia.
Plain-language title generated from the registry record
Registry title: Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Key facts
- Where
- Anaheim, Atlanta, Austin, Avon Lake, Bellaire, Birmingham, Boston, Brandon, Brooklyn, Bryant, Buffalo, Chandler, Charleston, Chicago, Cincinnati, Colton, Columbus, Dallas, Decatur, Denver, Draper, Dunwoody, Edmond, Elgin, Encino, Everett, Farmington, Fort Worth, Garland, Glendale, Hialeah, Hickory, Homestead, Houston, Jacksonville, Lake City, Largo, Las Vegas, Little Rock, Los Alamitos, Mankato, Miami, Middleburg Heights, Mount Kisco, Naperville, Naples, New York, North Bay Village, Oceanside, Orlando, Philadelphia, Portsmouth, Rancho Cucamonga, Redlands, Saint Augustine, San Jose, Santa Ana, Savannah, Sherman Oaks, Snellville, Stafford, Tampa, Tucson, Watertown, West Palm Beach, Wichita Falls, Winter Park, and Woodbury, United StatesSee the 84 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Source: NCT06559306, who can take part
Where in United States
- PAMOJA Clinical Institute LLCAnaheim, United StatesTaking people
- Agile Clinical Research Trials, LLCAtlanta, United StatesTaking people
- Advanced Discovery ResearchAtlanta, United StatesNo longer taking part
- BioBehavioral Research of Austin PCAustin, United StatesNo longer taking part
- The University of Texas at AustinAustin, United StatesNo longer taking part
- Haidar Almhana NiedingAvon Lake, United StatesNo longer taking part
- Houston Clinical Trials, LLCBellaire, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Boston Clinical TrialsBoston, United StatesNo longer taking part
- Clinical Research of BrandonBrandon, United StatesTaking people
- Integrative Clinical Trials, LLCBrooklyn, United StatesTaking people
- SPRI Clinical Trials, LLCBrooklyn, United StatesTaking people
- SanRo Clinical Research Group LLC WCG Clinical NetworkBryant, United StatesTaking people
- University at Buffalo PsychiatryBuffalo, United StatesNo longer taking part
- Chandler Clinical TrialsChandler, United StatesNo longer taking part
- Clinical Trials of South CarolinaCharleston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesTaking people
- MetroMed Clinical ResearchChicago, United StatesNo longer taking part
- University of Chicago Medical CenterChicago, United StatesNo longer taking part
- Patient Priority Clinical Sites LLCCincinnati, United StatesTaking people
- University of Cincinnati College of MedicineCincinnati, United StatesNo longer taking part
- Axiom ResearchColton, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- Relaro Medical TrialsDallas, United StatesNo longer taking part
- iResearch Atlanta, LLCDecatur, United StatesNo longer taking part
- Mountain View Clinical ResearchDenver, United StatesTaking people
- Cedar Clinical ResearchDraper, United StatesNo longer taking part
- Peachford Hospital-Atlanta Behavorial ResearchDunwoody, United StatesNo longer taking part
- Conrad Clinical ResearchEdmond, United StatesTaking people
- Revive Research InstituteElgin, United StatesNo longer taking part
- Elite Research Network 6Encino, United StatesNo longer taking part
- Core Clinical ResearchEverett, United StatesTaking people
- UConn Health CenterFarmington, United StatesTaking people
- North Texas Clinical TrialsFort Worth, United StatesTaking people
- VAST Clinical ResearchGarland, United StatesNo longer taking part
- Behavioral Research Specialists, LLCGlendale, United StatesTaking people
- AGA Clinical TrialsHialeah, United StatesNo longer taking part
- Reliable Clinical ResearchHialeah, United StatesNo longer taking part
- IMA Clinical Research PC 3Hickory, United StatesNo longer taking part
- Advanced Research Institute of MiamiHomestead, United StatesNo longer taking part
- Baylor College of MedicineHouston, United StatesTaking people
- DM Clinical ResearchHouston, United StatesNo longer taking part
- Clinical NeuroScience Solutions IncJacksonville, United StatesNo longer taking part
- Multi-Specialty Research Associates, Inc.Lake City, United StatesNo longer taking part
- Alcanza Clinical ResearchLargo, United StatesNo longer taking part
- Oasis Clinical Research LLCLas Vegas, United StatesNo longer taking part
- Redbird ResearchLas Vegas, United StatesNo longer taking part
- Preferred Research PartnersLittle Rock, United StatesNo longer taking part
- WR PRI Los AlamitosLos Alamitos, United StatesNo longer taking part
- Mankato ClinicMankato, United StatesNo longer taking part
- Nuovida Research CenterMiami, United StatesTaking people
- Miami Dade Medical Research InstituteMiami, United StatesNo longer taking part
- Pharmax Research Clinic IncMiami, United StatesNo longer taking part
- North Star Medical ResearchMiddleburg Heights, United StatesNo longer taking part
- Bioscience Research LLCMount Kisco, United StatesTaking people
- Baber Research GroupNaperville, United StatesTaking people
- Aqualane Clinical ResearchNaples, United StatesNo longer taking part
- Fieve Clinical Research, IncNew York, United StatesTaking people
- Hapworth Psychiatric Medical PLLCNew York, United StatesNo longer taking part
- Bravo Health Care CenterNorth Bay Village, United StatesNo longer taking part
- Excell Research, Inc.Oceanside, United StatesTaking people
- Nova Psychiatry Inc.Orlando, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- ActivMed Practices and ResearchPortsmouth, United StatesNo longer taking part
- Prospective Research Innovations IncRancho Cucamonga, United StatesNo longer taking part
- Anderson Clinical ResearchRedlands, United StatesTaking people
- Florida Center for TMSSaint Augustine, United StatesNo longer taking part
- Lumos Clinical Research Center LLCSan Jose, United StatesTaking people
- Syrentis Clinical ResearchSanta Ana, United StatesNo longer taking part
- iResearch SavannahSavannah, United StatesNo longer taking part
- California Neuroscience ResearchSherman Oaks, United StatesNo longer taking part
- Accelerated Clinical Research Group LLCSnellville, United StatesNo longer taking part
- Renew Health Clinical ResearchSnellville, United StatesNo longer taking part
- R and H Clinical ResearchStafford, United StatesNo longer taking part
- Interventional Psychiatry of Tampa BayTampa, United StatesTaking people
- Psych Me Medical Research IncTampa, United StatesTaking people
- University of South FloridaTampa, United StatesNo longer taking part
- University of ArizonaTucson, United StatesTaking people
- Adams Clinical LLCWatertown, United StatesTaking people
- Health Synergy Clinical ResearchWest Palm Beach, United StatesTaking people
- Grayline Research CenterWichita Falls, United StatesTaking people
- Conquest ResearchWinter Park, United StatesNo longer taking part
- Lucian Miron Manu MD Psychiatry PCWoodbury, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06559306EU 2023-509070-36-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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 Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis; Has current signs/symptoms of hypothyroidism or hyperthyroidism; Participants taking thyroid supplementation for antidepressant purposes.