Actively Recruiting
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
752
Participants Needed
205
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet DSM-5 criteria for major depressive disorder without psychotic features, confirmed by clinical interview
- First depressive episode occurred before age 60
- Had an inadequate response to 1 or 2 antidepressants at adequate dose and duration during current episode
- Currently receiving and tolerating a stable dose of an SSRI or SNRI for at least 6 weeks
- Have a major depressive episode of at least moderate severity with no clinically significant improvement during screening
- For Part 2 participants: completed Part 1 treatment phase, tolerate study drug well, medically stable, and able to follow study procedures
You will not qualify if you...
- Recent or current severe kidney, heart, lung, stomach, nerve, blood, joint, immune, or endocrine disorders or uncontrolled diabetes
- History of narcolepsy or seizures
- Current signs or symptoms of thyroid disorders
- Taking thyroid supplements for depression
- Diagnosis of Cushing's disease, Addison's disease, primary amenorrhea, or other significant HPA axis disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 205 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Chandler Clinical Trials
Chandler, Arizona, United States, 85224
Completed
3
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
4
SanRo Clinical Research Group LLC WCG Clinical Network
Bryant, Arkansas, United States, 72022
Actively Recruiting
5
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
Completed
6
PAMOJA Clinical Institute LLC
Anaheim, California, United States, 92801
Actively Recruiting
7
Axiom Research
Colton, California, United States, 92324
Actively Recruiting
8
Elite Research Network 6
Encino, California, United States, 91316
Completed
9
Behavioral Research Specialists LLC
Glendale, California, United States, 91206
Completed
10
WR PRI Los Alamitos
Los Alamitos, California, United States, 90720
Completed
11
Excell Research Inc
Oceanside, California, United States, 92056
Actively Recruiting
12
Prospective Research Innovations Inc
Rancho Cucamonga, California, United States, 91730
Completed
13
Anderson Clinical Research
Redlands, California, United States, 92374
Actively Recruiting
14
Lumos Clinical Research Center LLC
San Jose, California, United States, 95124
Actively Recruiting
15
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Completed
16
California Neuroscience Research
Sherman Oaks, California, United States, 91403
Completed
17
Mountain View Clinical Research
Denver, Colorado, United States, 80209
Actively Recruiting
18
UConn Health Center
Farmington, Connecticut, United States, 06030
Actively Recruiting
19
Clinical Research of Brandon
Brandon, Florida, United States, 33511
Actively Recruiting
20
AGA Clinical Trials
Hialeah, Florida, United States, 33012
Actively Recruiting
21
Reliable Clinical Research
Hialeah, Florida, United States, 33012
Actively Recruiting
22
Advanced Research Institute of Miami
Homestead, Florida, United States, 33033
Actively Recruiting
23
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, United States, 32256
Actively Recruiting
24
Multi Specialty Research Associates Inc
Lake City, Florida, United States, 32055
Completed
25
Alcanza Clinical Research
Largo, Florida, United States, 33777
Completed
26
Pharmax Research Clinic Inc
Miami, Florida, United States, 33126
Actively Recruiting
27
Miami Dade Medical Research Institute
Miami, Florida, United States, 33176
Actively Recruiting
28
Nuovida Research Center
Miami, Florida, United States, 33186
Actively Recruiting
29
Aqualane Clinical Research
Naples, Florida, United States, 34105
Completed
30
Bravo Health Care Center
North Bay Village, Florida, United States, 33141
Completed
31
Nova Psychiatry INC
Orlando, Florida, United States, 32803
Actively Recruiting
32
Florida Center for TMS
Saint Augustine, Florida, United States, 32086
Completed
33
University of South Florida
Tampa, Florida, United States, 33613
Completed
34
Psych Me Medical Research Inc
Tampa, Florida, United States, 33614
Actively Recruiting
35
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States, 33629
Actively Recruiting
36
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
37
Conquest Research
Winter Park, Florida, United States, 32789
Completed
38
Advanced Discovery Research
Atlanta, Georgia, United States, 30318
Actively Recruiting
39
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States, 30328
Active, Not Recruiting
40
iResearch Atlanta LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
41
Peachford Hospital-Atlanta Behavorial Research
Dunwoody, Georgia, United States, 30338
Completed
42
iResearch Savannah
Savannah, Georgia, United States, 31405
Completed
43
Accelerated Clinical Research Group LLC
Snellville, Georgia, United States, 30078
Actively Recruiting
44
Renew Health Clinical Research
Snellville, Georgia, United States, 30078
Completed
45
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
46
MetroMed Clinical Research
Chicago, Illinois, United States, 60614
Completed
47
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
48
Revive Research Institute
Elgin, Illinois, United States, 60123
Completed
49
Baber Research Group
Naperville, Illinois, United States, 60563
Actively Recruiting
50
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Completed
51
Adams Clinical LLC
Watertown, Massachusetts, United States, 02472
Actively Recruiting
52
Mankato Clinic
Mankato, Minnesota, United States, 56001
Actively Recruiting
53
Redbird Research
Las Vegas, Nevada, United States, 89119
Completed
54
Oasis Clinical Research LLC
Las Vegas, Nevada, United States, 89121
Completed
55
ActivMed Practices and Research
Portsmouth, New Hampshire, United States, 03801
Completed
56
Integrative Clinical Trials LLC
Brooklyn, New York, United States, 11229
Actively Recruiting
57
SPRI Clinical Trials, LLC
Brooklyn, New York, United States, 11235
Actively Recruiting
58
University at Buffalo Psychiatry
Buffalo, New York, United States, 14202
Completed
59
Bioscience Research LLC
Mount Kisco, New York, United States, 10549
Actively Recruiting
60
Fieve Clinical Research Inc
New York, New York, United States, 10017
Actively Recruiting
61
Hapworth Psychiatric Medical PLLC
New York, New York, United States, 10022
Completed
62
Lucian Miron Manu MD Psychiatry PC
Woodbury, New York, United States, 11797
Completed
63
IMA Clinical Research PC 3
Hickory, North Carolina, United States, 28601
Completed
64
Haidar Almhana Nieding
Avon Lake, Ohio, United States, 44012
Completed
65
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States, 45215
Actively Recruiting
66
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45219
Completed
67
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
68
North Star Medical Research
Middleburg Heights, Ohio, United States, 44130
Completed
69
Conrad Clinical Research
Edmond, Oklahoma, United States, 73013
Actively Recruiting
70
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
71
Clinical Trials of South Carolina
Charleston, South Carolina, United States, 29406
Actively Recruiting
72
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Completed
73
The University of Texas at Austin
Austin, Texas, United States, 78712
Completed
74
BioBehavioral Research of Austin PC
Austin, Texas, United States, 78759
Completed
75
Houston Clinical Trials LLC
Bellaire, Texas, United States, 77401
Actively Recruiting
76
Relaro Medical Trials
Dallas, Texas, United States, 75243
Completed
77
North Texas Clinical Trials
Fort Worth, Texas, United States, 76104
Actively Recruiting
78
VAST Clinical Research
Garland, Texas, United States, 75041
Completed
79
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
80
DM Clinical Research
Houston, Texas, United States, 77081
Actively Recruiting
81
R and H Clinical Research
Stafford, Texas, United States, 77477
Actively Recruiting
82
Grayline Research Center
Wichita Falls, Texas, United States, 76309
Active, Not Recruiting
83
Cedar Clinical Research
Draper, Utah, United States, 84020
Completed
84
Core Clinical Research
Everett, Washington, United States, 98201
Actively Recruiting
85
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, Argentina, C1133AAH
Active, Not Recruiting
86
CEN Consultorios Especializados en Neurociencias
Córdoba, Argentina, 5000FJF
Actively Recruiting
87
Instituto Medico DAMIC
Córdoba, Argentina, X5003DCE
Actively Recruiting
88
Centro Medico Luquez
Córdoba, Argentina, X5006IKK
Actively Recruiting
89
Sanatorio Prof Leon S Morra S A
Córdoba, Argentina, X5009BIN
Actively Recruiting
90
INSA Instituto de Neurociencias San Agustín
La Plata, Argentina, 1900
Actively Recruiting
91
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, Argentina, 2000
Actively Recruiting
92
Clinica El Jardin
Santiago del Estero, Argentina, 4200
Actively Recruiting
93
L2IP Instituto de Pesquisas Clinicas
Brasília, Brazil, 70200 730
Suspended
94
CAEP Centro Avancado De Estudos E Pesquisas
Campinas, Brazil, 13087 567
Actively Recruiting
95
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, Brazil, 88811 000
Actively Recruiting
96
Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
Natal, Brazil, 59012 300
Completed
97
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Brazil, 99010 120
Suspended
98
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil, 90035 903
Completed
99
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Brazil, 90430001
Actively Recruiting
100
Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Brazil, 90619900
Completed
101
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, Brazil, 22270 060
Actively Recruiting
102
Centro Integrado Facili
São Bernardo do Campo, Brazil, 09726 150
Actively Recruiting
103
CPQuali Pesquisa Clinica LTDA ME
São Paulo, Brazil, 01228 000
Active, Not Recruiting
104
BR Trials
São Paulo, Brazil, 01236030
Actively Recruiting
105
Mental Health Center Prof. Dr. Ivan Temkov
Burgas, Bulgaria, 8001
Active, Not Recruiting
106
UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
Plovdiv, Bulgaria, 4002
Actively Recruiting
107
Medical Center St. Naum
Sofia, Bulgaria, 1113
Actively Recruiting
108
Centre for Mental Health Prof.N.Shipkovenski EOOD
Sofia, Bulgaria, 1377
Completed
109
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, Bulgaria, 1408
Actively Recruiting
110
Medical Center ZaraMed
Stara Zagora, Bulgaria, 6003
Completed
111
Diagnostic Consulting Center Mladost - M Varna
Varna, Bulgaria, 9020
Active, Not Recruiting
112
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, Colombia, 080002
Actively Recruiting
113
HOMO - ESE Hospital Mental de Antioquia
Bello, Colombia, 051053
Actively Recruiting
114
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
Bogotá, Colombia, 111166
Actively Recruiting
115
Psynapsis Salud Mental S.A.
Pereira, Colombia, 660001
Actively Recruiting
116
Medipa S R O
Brno, Czechia, 61300
Actively Recruiting
117
A Shine S R O
Pilsen, Czechia, 301 00
Completed
118
Clintrial s r o
Prague, Czechia, 10000
Actively Recruiting
119
Neuropsychiatrie Petrska sro
Prague, Czechia, 110 00
Actively Recruiting
120
Pragtis S R O
Prague, Czechia, 12000
Completed
121
Medical Services Prague S R O
Prague, Czechia, 16000
Actively Recruiting
122
Territorial Social Health Authority of the Spedali Civili of Brescia
Brescia, Italy, 25123
Completed
123
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, Italy, 95123
Actively Recruiting
124
Universita D Annunzio
Chieti, Italy, 66100
Actively Recruiting
125
IRCCS Aor San Martino IST
Genova, Italy, 16132
Completed
126
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Completed
127
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Completed
128
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Completed
129
Azienda Ospedaliera Sant Andrea
Roma, Italy, 00189
Actively Recruiting
130
Ospedale S Francesco d Assisi
Salerno, Italy, 84020
Completed
131
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, Italy, 53100
Actively Recruiting
132
Health Pharma Professional Research
Mexico City, Mexico, 03100
Completed
133
Ketamine Mexico S de RL de C V
Mexico City, Mexico, 04100
Actively Recruiting
134
Gabipros SC
Mexico City, Mexico, 07000
Actively Recruiting
135
Instituto de Informacion e Investigacion en Salud Mental A.C.
Monterrey, Mexico, 64710
Actively Recruiting
136
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, Mexico, 64460
Actively Recruiting
137
Centro de Estudios Clinicos y Especialidades Medicas S C
Nuevo León, Mexico, 64620
Actively Recruiting
138
Hospital Lomas de San Luis Internacional
San Luis de Potosi, Mexico, 78218
Actively Recruiting
139
Centrum Medyczne Intercor Sp z o o
Bydgoszcz, Poland, 85 605
Completed
140
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Bydgoszcz, Poland, 85 794
Actively Recruiting
141
PROMENTE Sp. z o.o.
Bydgoszcz, Poland, 85-133
Actively Recruiting
142
Centrum Zdrowia Alcea
Gdansk, Poland, 80 283
Actively Recruiting
143
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Gorlice, Poland, 30073
Completed
144
Przychodnie Grudziadz sp. z o.o.
Grudziądz, Poland, 86 300
Actively Recruiting
145
Clinic BBP
Katowice, Poland, 40 514
Actively Recruiting
146
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, Poland, 64-100
Actively Recruiting
147
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Poznan, Poland, 60 192
Actively Recruiting
148
Szpital Nowowiejski Osrodek Badan Klinicznych
Warsaw, Poland, 00-774
Actively Recruiting
149
MTZ Clinical Research Powered by Pratia
Warsaw, Poland, 02-172
Completed
150
Uls Braga - Hosp. Braga
Braga, Portugal, 4710 243
Completed
151
Uls Regiao Leiria - Hosp. Santo Andre
Leiria, Portugal, 2410 197
Actively Recruiting
152
Uls Lisboa Ocidental - Hosp. Egas Moniz
Lisbon, Portugal, 1349 019
Actively Recruiting
153
Fund. Champalimaud
Lisbon, Portugal, 1400 038
Actively Recruiting
154
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal, 1649 035
Completed
155
Uls Loures Odivelas - Hosp. Loures
Loures, Portugal, 2674 514
Actively Recruiting
156
Hosp. Divino Espirito Santo Ponta Delgada
Ponta Delgada, Portugal, 9500 370
Actively Recruiting
157
Hosp. Cuf Porto
Porto, Portugal, 4100 180
Actively Recruiting
158
Hosp. Central Trofa Saude
Touguinho, Portugal, 4480-565
Completed
159
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2
Bucharest, Romania, 041914
Completed
160
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, Romania, 041914
Actively Recruiting
161
Spitalul Clinic Judetean de Urgenta Cluj Napoca 1
Cluj-Napoca, Romania, 400012
Completed
162
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, Romania, 400012
Completed
163
Centrul Medical Melchisedec
Craiova, Romania, 200157
Actively Recruiting
164
CMI Dr. Sarpe Marcel-Claudiu
Focşani, Romania, 620117
Completed
165
Institutului Regional de Psihiatrie 'Socola' Iasi
Iași, Romania, 700282
Completed
166
Institutului Regional de Psihiatrie Socola Iasi 1
Iași, Romania, 700282
Completed
167
Institutului Regional de Psihiatrie Socola Iasi 2
Iași, Romania, 700282
Completed
168
Spitalul Clinic Judetean de Urgenta Oradea
Oradea, Romania, 410169
Actively Recruiting
169
Spitalul de Psihiatrie si Neurologie Brasov
Sânpetru, Romania, 507190
Actively Recruiting
170
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1
Sibiu, Romania, 550082
Completed
171
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, Romania, 550082
Completed
172
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
173
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
Belgrade, Serbia, 11000
Actively Recruiting
174
Special Hospital for Psychiatric Diseases Gornja Toponica
Gornja Toponica, Serbia, 18202
Actively Recruiting
175
Special Hospital for Psychiatric Diseases Kovin
Kovin, Serbia, 26220
Actively Recruiting
176
Specialized Hospital for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, Serbia, 23330
Actively Recruiting
177
Psychiatricka Ambulancia Mentum S.R.O.
Bratislava, Slovakia, 821 01
Completed
178
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia, 040 01
Actively Recruiting
179
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
Liptovský Mikuláš, Slovakia, 031 23
Actively Recruiting
180
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavská Sobota, Slovakia, 979 01
Actively Recruiting
181
Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
Svidník, Slovakia, 089 01
Actively Recruiting
182
Crystal Comfort s.r.o.
Vranov nad Topľou, Slovakia, 093 01
Actively Recruiting
183
Institucion Hosp Hestia Palau
Barcelona, Spain, 08025
Actively Recruiting
184
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
185
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
186
Hosp. Univ. de Basurto
Bilbao, Spain, 48013
Completed
187
Hosp. Gral. de Villalba
Collado Villalba, Spain, 28400
Actively Recruiting
188
Hosp. Univ. Infanta Leonor
Madrid, Spain, 28031
Actively Recruiting
189
Hospital Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
190
Hosp. Univ. La Paz
Madrid, Spain, 28046
Actively Recruiting
191
Hosp. Univ. de Torrevieja
Torrevieja, Spain, 03186
Actively Recruiting
192
ProbarE i Lund AB
Lund, Sweden, 22222
Actively Recruiting
193
CTC GoCo
Mölndal, Sweden, 43153
Actively Recruiting
194
ProbarE i Stockholm AB
Stockholm, Sweden, 114 37
Actively Recruiting
195
CTC MTC Uppsala
Uppsala, Sweden, 75237
Actively Recruiting
196
Gulhane Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
197
Ankara University Medical Faculty
Ankara, Turkey (Türkiye), 06620
Completed
198
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
199
Uludag Universitesi Tıp Fakultesi Hastanesi
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
200
Bursa High Speciality Training and Research Dortcelik Mental Hospital
Bursa, Turkey (Türkiye), 16285
Completed
201
Gaziantep Universitesi Tip Fakultesi
Gaziantep, Turkey (Türkiye), 27580
Actively Recruiting
202
Erenkoy Mental Hospital
Istanbul, Turkey (Türkiye), 34736
Completed
203
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye), 41001
Actively Recruiting
204
Liv Hospital
Samsun, Turkey (Türkiye), 55020
Actively Recruiting
205
Karadeniz Teknik University Medical Faculty
Trabzon, Turkey (Türkiye), 61080
Completed
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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