Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
NCT ID: NCT06559306
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
752 participants
INTERVENTIONAL
2024-07-25
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: Seltorexant
Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.
Seltorexant
Seltorexant will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
SSRI/SNRI will be administered orally.
Part 1: Placebo
Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Placebo
Matching Placebo tablets will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
SSRI/SNRI will be administered orally.
Part 2: Open Label (OL) Seltorexant
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.
Seltorexant
Seltorexant will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
SSRI/SNRI will be administered orally.
Part 2: DB Seltorexant
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Seltorexant
Seltorexant will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
SSRI/SNRI will be administered orally.
Part 2: DB Placebo
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Placebo
Matching Placebo tablets will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
SSRI/SNRI will be administered orally.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
74 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trail
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Chandler Clinical Trials
Chandler, Arizona, United States
University of Arizona
Tucson, Arizona, United States
SanRo Clinical Research Group LLC WCG Clinical Network
Bryant, Arkansas, United States
Preferred Research Partners
Little Rock, Arkansas, United States
PAMOJA Clinical Institute LLC
Anaheim, California, United States
Axiom Research
Colton, California, United States
Elite Research Network
Encino, California, United States
Behavioral Research Specialists LLC
Glendale, California, United States
WR PRI Los Alamitos
Los Alamitos, California, United States
Excell Research Inc
Oceanside, California, United States
Prospective Research Innovations Inc
Rancho Cucamonga, California, United States
Anderson Clinical Research
Redlands, California, United States
Lumos Clinical Research Center LLC
San Jose, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
California Neuroscience Research
Sherman Oaks, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
UConn Health Center
Farmington, Connecticut, United States
Clinical Research of Brandon
Brandon, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Reliable Clinical Research
Hialeah, Florida, United States
Advanced Research Institute of Miami
Homestead, Florida, United States
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, United States
Multi Specialty Research Associates Inc
Lake City, Florida, United States
Alcanza Clinical Research
Largo, Florida, United States
Pharmax Research Clinic Inc
Miami, Florida, United States
Miami Dade Medical Research Institute
Miami, Florida, United States
Nuovida Research Center
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Bravo Health Care Center
North Bay Village, Florida, United States
Nova Psychiatry INC
Orlando, Florida, United States
Florida Center for TMS
Saint Augustine, Florida, United States
University of South Florida
Tampa, Florida, United States
Psych Me Medical Research Inc
Tampa, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Advanced Discovery Research
Atlanta, Georgia, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
Peachford Hospital-Atlanta Behavorial Research
Dunwoody, Georgia, United States
Accelerated Clinical Research Group LLC
Peachtree Corners, Georgia, United States
iResearch Savannah
Savannah, Georgia, United States
Renew Health Clinical Research
Snellville, Georgia, United States
Northwestern University
Chicago, Illinois, United States
MetroMed Clinical Research
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Revive Research Institute
Elgin, Illinois, United States
Baber Research Group
Naperville, Illinois, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Adams Clinical LLC
Watertown, Massachusetts, United States
Mankato Clinic
Mankato, Minnesota, United States
Redbird Research
Las Vegas, Nevada, United States
Oasis Clinical Research LLC
Las Vegas, Nevada, United States
ActivMed Practices and Research
Portsmouth, New Hampshire, United States
Integrative Clinical Trials LLC
Brooklyn, New York, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
University at Buffalo Psychiatry
Buffalo, New York, United States
Bioscience Research LLC
Mount Kisco, New York, United States
Fieve Clinical Research Inc
New York, New York, United States
Hapworth Psychiatric Medical PLLC
New York, New York, United States
Lucian Miron Manu MD Psychiatry PC
Woodbury, New York, United States
IMA Clinical Research PC
Hickory, North Carolina, United States
Haidar Almhana Nieding
Avon Lake, Ohio, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
North Star Medical Research
Middleburg Heights, Ohio, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Texas at Austin
Austin, Texas, United States
BioBehavioral Research of Austin PC
Austin, Texas, United States
Houston Clinical Trials LLC
Bellaire, Texas, United States
Relaro Medical Trials
Dallas, Texas, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
VAST Clinical Research
Garland, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
DM Clinical Research
Houston, Texas, United States
R and H Clinical Research
Stafford, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Core Clinical Research
Everett, Washington, United States
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, , Argentina
CEN Consultorios Especializados en Neurociencias
Córdoba, , Argentina
Instituto Medico DAMIC
Córdoba, , Argentina
Centro Medico Luquez
Córdoba, , Argentina
Sanatorio Prof Leon S Morra S A
Córdoba, , Argentina
INSA Instituto de Neurociencias San Agustín
La Plata, , Argentina
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, , Argentina
Clinica El Jardin
Santiago del Estero, , Argentina
L2IP Instituto de Pesquisas Clinicas
Brasília, , Brazil
CAEP Centro Avancado De Estudos E Pesquisas
Campinas, , Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, , Brazil
Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
Natal, , Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, , Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, , Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, , Brazil
Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, , Brazil
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, , Brazil
Centro Integrado Facili
São Bernardo do Campo, , Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, , Brazil
BR Trials
São Paulo, , Brazil
Mental Health Center Prof. Dr. Ivan Temkov
Burgas, , Bulgaria
UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
Plovdiv, , Bulgaria
Medical Center St. Naum
Sofia, , Bulgaria
Centre for Mental Health Prof.N.Shipkovenski EOOD
Sofia, , Bulgaria
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, , Bulgaria
Medical Center ZaraMed
Stara Zagora, , Bulgaria
Diagnostic Consulting Center Mladost - M Varna
Varna, , Bulgaria
Medipa S R O
Brno, , Czechia
A Shine S R O
Pilsen, , Czechia
Clintrial s r o
Prague, , Czechia
Neuropsychiatrie Petrska sro
Prague, , Czechia
Pragtis S R O
Prague, , Czechia
Medical Services Prague S R O
Prague, , Czechia
Territorial Social Health Authority of the Spedali Civili of Brescia
Brescia, , Italy
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, , Italy
Universita D Annunzio
Chieti, , Italy
IRCCS Aor San Martino IST
Genova, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Azienda Ospedaliera Sant Andrea
Roma, , Italy
Ospedale S Francesco d Assisi
Salerno, , Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, , Italy
Health Pharma Professional Research
Mexico City, , Mexico
Ketamine Mexico S de RL de C V
Mexico City, , Mexico
Gabipros SC
Mexico City, , Mexico
Instituto de Informacion e Investigacion en Salud Mental A.C.
Monterrey, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, , Mexico
Centro de Estudios Clinicos y Especialidades Medicas S C
Nuevo León, , Mexico
Hospital Lomas de San Luis Internacional
San Luis de Potosi, , Mexico
Centrum Medyczne Intercor Sp z o o
Bydgoszcz, , Poland
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Bydgoszcz, , Poland
PROMENTE Sp. z o.o.
Bydgoszcz, , Poland
Centrum Zdrowia Alcea
Gdansk, , Poland
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Gorlice, , Poland
NZOZ Euromedica Grudziadz
Grudziądz, , Poland
Clinic BBP
Katowice, , Poland
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, , Poland
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Poznan, , Poland
Szpital Nowowiejski Osrodek Badan Klinicznych
Warsaw, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Uls Braga - Hosp. Braga
Braga, , Portugal
Uls Regiao Leiria - Hosp. Santo Andre
Leiria, , Portugal
Uls Lisboa Ocidental - Hosp. Egas Moniz
Lisbon, , Portugal
Fund. Champalimaud
Lisbon, , Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, , Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, , Portugal
Hosp. Divino Espirito Santo Ponta Delgada
Ponta Delgada, , Portugal
Hosp. Cuf Porto
Porto, , Portugal
Hosp. Central Trofa Saude
Touguinho, , Portugal
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, , Romania
Centrul Medical Melchisedec
Craiova, , Romania
CMI Dr. Sarpe Marcel-Claudiu
Focşani, , Romania
Institutului Regional de Psihiatrie 'Socola' Iasi
Iași, , Romania
Spitalul Clinic Judetean de Urgenta Oradea
Oradea, , Romania
Spitalul de Psihiatrie si Neurologie Brasov
Sânpetru, , Romania
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, , Romania
University Clinical Center of Serbia
Belgrade, , Serbia
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
Belgrade, , Serbia
Special Hospital for Psychiatric Diseases Gornja Toponica
Gornja Toponica, , Serbia
Special Hospital for Psychiatric Diseases Kovin
Kovin, , Serbia
Specialized Hospital for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, , Serbia
Psychiatricka Ambulancia Mentum S.R.O.
Bratislava, , Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Košice, , Slovakia
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
Liptovský Mikuláš, , Slovakia
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavská Sobota, , Slovakia
Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
Svidník, , Slovakia
Crystal Comfort s.r.o.
Vranov nad Topľou, , Slovakia
Institucion Hosp Hestia Palau
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Univ. de Basurto
Bilbao, , Spain
Hosp. Gral. de Villalba
Collado Villalba, , Spain
Hosp. Univ. Infanta Leonor
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp. Univ. de Torrevieja
Torrevieja, , Spain
ProbarE i Lund AB
Lund, , Sweden
CTC GoCo
Mölndal, , Sweden
ProbarE i Stockholm AB
Stockholm, , Sweden
CTC MTC Uppsala
Uppsala, , Sweden
Gulhane Egitim ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Uludag Universitesi Tıp Fakultesi Hastanesi
Bursa, , Turkey (Türkiye)
Bursa High Speciality Training and Research Dortcelik Mental Hospital
Bursa, , Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi
Gaziantep, , Turkey (Türkiye)
Erenkoy Mental Hospital
Istanbul, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Liv Hospital
Samsun, , Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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42847922MDD3003
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509070-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
42847922MDD3003
Identifier Type: -
Identifier Source: org_study_id