Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Start Date
7/25/2024
Completion Date
12/30/2026
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 Criteria
Age Range: 18 years to 74 years
Interventions
Seltorexant
Placebo
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Chandler Clinical Trials
Chandler, Arizona 85224
United States
University of Arizona
Tucson, Arizona 85724
United States
SanRo Clinical Research Group LLC WCG Clinical Network
Bryant, Arkansas 72022
United States
Preferred Research Partners
Little Rock, Arkansas 72211
United States
PAMOJA Clinical Institute LLC
Anaheim, California 92801
United States
Axiom Research
Colton, California 92324
United States
Elite Research Network 6
Encino, California 91316
United States
Behavioral Research Specialists LLC
Glendale, California 91206
United States
WR PRI Los Alamitos
Los Alamitos, California 90720
United States
Excell Research Inc
Oceanside, California 92056
United States
Prospective Research Innovations Inc
Rancho Cucamonga, California 91730
United States
Anderson Clinical Research
Redlands, California 92374
United States
Lumos Clinical Research Center LLC
San Jose, California 95124
United States
Syrentis Clinical Research
Santa Ana, California 92705
United States
California Neuroscience Research
Sherman Oaks, California 91403
United States
Mountain View Clinical Research
Denver, Colorado 80209
United States
UConn Health Center
Farmington, Connecticut 06030
United States
Clinical Research of Brandon
Brandon, Florida 33511
United States
AGA Clinical Trials
Hialeah, Florida 33012
United States
Reliable Clinical Research
Hialeah, Florida 33012
United States
Advanced Research Institute of Miami
Homestead, Florida 33033
United States
Clinical NeuroScience Solutions Inc
Jacksonville, Florida 32256
United States
Multi Specialty Research Associates Inc
Lake City, Florida 32055
United States
Alcanza Clinical Research
Largo, Florida 33777
United States
Pharmax Research Clinic Inc
Miami, Florida 33126
United States
Miami Dade Medical Research Institute
Miami, Florida 33176
United States
Nuovida Research Center
Miami, Florida 33186
United States
Aqualane Clinical Research
Naples, Florida 34105
United States
Bravo Health Care Center
North Bay Village, Florida 33141
United States
Nova Psychiatry INC
Orlando, Florida 32803
United States
Florida Center for TMS
Saint Augustine, Florida 32086
United States
University of South Florida
Tampa, Florida 33613
United States
Psych Me Medical Research Inc
Tampa, Florida 33614
United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida 33629
United States
Health Synergy Clinical Research
West Palm Beach, Florida 33407
United States
Conquest Research
Winter Park, Florida 32789
United States
Advanced Discovery Research
Atlanta, Georgia 30318
United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328
United States
iResearch Atlanta LLC
Decatur, Georgia 30030
United States
Peachford Hospital-Atlanta Behavorial Research
Dunwoody, Georgia 30338
United States
iResearch Savannah
Savannah, Georgia 31405
United States
Accelerated Clinical Research Group LLC
Snellville, Georgia 30078
United States
Renew Health Clinical Research
Snellville, Georgia 30078
United States
Northwestern University
Chicago, Illinois 60611
United States
MetroMed Clinical Research
Chicago, Illinois 60614
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Revive Research Institute
Elgin, Illinois 60123
United States
Baber Research Group
Naperville, Illinois 60563
United States
Boston Clinical Trials
Boston, Massachusetts 02131
United States
Adams Clinical LLC
Watertown, Massachusetts 02472
United States
Mankato Clinic
Mankato, Minnesota 56001
United States
Redbird Research
Las Vegas, Nevada 89119
United States
Oasis Clinical Research LLC
Las Vegas, Nevada 89121
United States
ActivMed Practices and Research
Portsmouth, New Hampshire 03801
United States
Integrative Clinical Trials LLC
Brooklyn, New York 11229
United States
SPRI Clinical Trials, LLC
Brooklyn, New York 11235
United States
University at Buffalo Psychiatry
Buffalo, New York 14202
United States
Bioscience Research LLC
Mount Kisco, New York 10549
United States
Fieve Clinical Research Inc
New York, New York 10017
United States
Hapworth Psychiatric Medical PLLC
New York, New York 10022
United States
Lucian Miron Manu MD Psychiatry PC
Woodbury, New York 11797
United States
IMA Clinical Research PC 3
Hickory, North Carolina 28601
United States
Haidar Almhana Nieding
Avon Lake, Ohio 44012
United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio 45215
United States
University of Cincinnati College of Medicine
Cincinnati, Ohio 45219
United States
The Ohio State University
Columbus, Ohio 43210
United States
North Star Medical Research
Middleburg Heights, Ohio 44130
United States
Conrad Clinical Research
Edmond, Oklahoma 73013
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Clinical Trials of South Carolina
Charleston, South Carolina 29406
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
The University of Texas at Austin
Austin, Texas 78712
United States
BioBehavioral Research of Austin PC
Austin, Texas 78759
United States
Houston Clinical Trials LLC
Bellaire, Texas 77401
United States
Relaro Medical Trials
Dallas, Texas 75243
United States
North Texas Clinical Trials
Fort Worth, Texas 76104
United States
VAST Clinical Research
Garland, Texas 75041
United States
Baylor College of Medicine
Houston, Texas 77030
United States
DM Clinical Research
Houston, Texas 77081
United States
R and H Clinical Research
Stafford, Texas 77477
United States
Grayline Research Center
Wichita Falls, Texas 76309
United States
Cedar Clinical Research
Draper, Utah 84020
United States
Core Clinical Research
Everett, Washington 98201
United States
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, C1133AAH
Argentina
CEN Consultorios Especializados en Neurociencias
Córdoba, 5000FJF
Argentina
Instituto Medico DAMIC
Córdoba, X5003DCE
Argentina
Centro Medico Luquez
Córdoba, X5006CBI
Argentina
Sanatorio Prof Leon S Morra S A
Córdoba, X5009BIN
Argentina
INSA Instituto de Neurociencias San Agustín
La Plata, 1900
Argentina
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, 2000
Argentina
Clinica El Jardin
Santiago del Estero, 4200
Argentina
L2IP Instituto de Pesquisas Clinicas
Brasília, 70200 730
Brazil
CAEP Centro Avancado De Estudos E Pesquisas
Campinas, 13087 567
Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, 88811 000
Brazil
Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
Natal, 59012 300
Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, 99010 120
Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903
Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, 90430001
Brazil
Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, 90619900
Brazil
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, 22270 060
Brazil
Centro Integrado Facili
São Bernardo do Campo, 09726 150
Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, 01228 000
Brazil
BR Trials
São Paulo, 01236030
Brazil
Mental Health Center Prof. Dr. Ivan Temkov
Burgas, 8001
Bulgaria
UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
Plovdiv, 4002
Bulgaria
Medical Center St. Naum
Sofia, 1113
Bulgaria
Centre for Mental Health Prof.N.Shipkovenski EOOD
Sofia, 1377
Bulgaria
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, 1408
Bulgaria
Medical Center ZaraMed
Stara Zagora, 6010
Bulgaria
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020
Bulgaria
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, 080002
Colombia
HOMO - ESE Hospital Mental de Antioquia
Bello, 051053
Colombia
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
Bogotá, 111166
Colombia
Psynapsis Salud Mental S.A.
Pereira, 660001
Colombia
Medipa S R O
Brno, 61300
Czechia
A Shine S R O
Pilsen, 301 00
Czechia
Clintrial s r o
Prague, 10000
Czechia
Neuropsychiatrie Petrska sro
Prague, 110 00
Czechia
Pragtis S R O
Prague, 12000
Czechia
Medical Services Prague S R O
Prague, 16000
Czechia
Territorial Social Health Authority of the Spedali Civili of Brescia
Brescia, 25123
Italy
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, 95123
Italy
Universita D Annunzio
Chieti, 66100
Italy
IRCCS Aor San Martino IST
Genova, 16132
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168
Italy
Azienda Ospedaliera Sant Andrea
Roma, 00189
Italy
Ospedale S Francesco d Assisi
Salerno, 84020
Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, 53100
Italy
Health Pharma Professional Research
Mexico City, 03100
Mexico
Ketamine Mexico S de RL de C V
Mexico City, 04100
Mexico
Gabipros SC
Mexico City, 07000
Mexico
Instituto de Informacion e Investigacion en Salud Mental A.C.
Monterrey, 64710
Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, 64460
Mexico
Centro de Estudios Clinicos y Especialidades Medicas S C
Nuevo León, 64620
Mexico
Hospital Lomas de San Luis Internacional
San Luis de Potosi, 78218
Mexico
Centrum Medyczne Intercor Sp z o o
Bydgoszcz, 85 605
Poland
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Bydgoszcz, 85 794
Poland
PROMENTE Sp. z o.o.
Bydgoszcz, 85-133
Poland
Centrum Zdrowia Alcea
Gdansk, 80 283
Poland
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Gorlice, 30073
Poland
Przychodnie Grudziadz sp. z o.o.
Grudziądz, 86 300
Poland
Clinic BBP Sp z o o
Katowice, 40 514
Poland
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100
Poland
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Poznan, 60 192
Poland
Szpital Nowowiejski Osrodek Badan Klinicznych
Warsaw, 00-774
Poland
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
Poland
Uls Braga - Hosp. Braga
Braga, 4710 243
Portugal
Uls Regiao Leiria - Hosp. Santo Andre
Leiria, 2410 197
Portugal
Uls Lisboa Ocidental - Hosp. Egas Moniz
Lisbon, 1349 019
Portugal
Fund. Champalimaud
Lisbon, 1400 038
Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 035
Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, 2674 514
Portugal
Hosp. Divino Espirito Santo Ponta Delgada
Ponta Delgada, 9500 370
Portugal
Hosp. Cuf Porto
Porto, 4100 180
Portugal
Hosp. Central Trofa Saude
Touguinho, 4480-565
Portugal
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2
Bucharest, 041914
Romania
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, 041914
Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca 1
Cluj-Napoca, 400012
Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400012
Romania
Centrul Medical Melchisedec
Craiova, 200157
Romania
CMI Dr. Sarpe Marcel-Claudiu
Focşani, 620117
Romania
Institutului Regional de Psihiatrie 'Socola' Iasi
Iași, 700282
Romania
Institutului Regional de Psihiatrie Socola Iasi 1
Iași, 700282
Romania
Institutului Regional de Psihiatrie Socola Iasi 2
Iași, 700282
Romania
Spitalul Clinic Judetean de Urgenta Oradea
Oradea, 410169
Romania
Spitalul de Psihiatrie si Neurologie Brasov
Sânpetru, 507190
Romania
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1
Sibiu, 550082
Romania
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, 550082
Romania
University Clinical Center of Serbia
Belgrade, 11000
Serbia
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
Belgrade, 11000
Serbia
Special Hospital for Psychiatric Diseases Gornja Toponica
Gornja Toponica, 18202
Serbia
Special Hospital for Psychiatric Diseases Kovin
Kovin, 26220
Serbia
Specialized Hospital for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330
Serbia
Psychiatricka Ambulancia Mentum S.R.O.
Bratislava, 821 01
Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Košice, 040 01
Slovakia
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
Liptovský Mikuláš, 031 23
Slovakia
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavská Sobota, 979 01
Slovakia
Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
Svidník, 089 01
Slovakia
Crystal Comfort s.r.o.
Vranov nad Topľou, 093 01
Slovakia
Institucion Hosp Hestia Palau
Barcelona, 08025
Spain
Hosp Clinic de Barcelona
Barcelona, 08036
Spain
Hosp Univ Vall D Hebron
Barcelona, 8035
Spain
Hosp. Univ. de Basurto
Bilbao, 48013
Spain
Hosp. Gral. de Villalba
Collado Villalba, 28400
Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031
Spain
Hospital Ramon y Cajal
Madrid, 28034
Spain
Hosp. Univ. La Paz
Madrid, 28046
Spain
Hosp. Univ. de Torrevieja
Torrevieja, 03186
Spain
ProbarE i Lund AB
Lund, 22222
Sweden
CTC GoCo
Mölndal, 43153
Sweden
ProbarE i Stockholm AB
Stockholm, 114 37
Sweden
CTC MTC Uppsala
Uppsala, 75237
Sweden
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010
Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06620
Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
Turkey (Türkiye)
Uludag Universitesi Tıp Fakultesi Hastanesi
Bursa, 16059
Turkey (Türkiye)
Bursa High Speciality Training and Research Dortcelik Mental Hospital
Bursa, 16285
Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi
Gaziantep, 27580
Turkey (Türkiye)
Erenkoy Mental Hospital
Istanbul, 34736
Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41001
Turkey (Türkiye)
Liv Hospital
Samsun, 55020
Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
Turkey (Türkiye)