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

PHASE3RecruitingINTERVENTIONAL
Enrollment

752

Participants

Timeline

Start Date

July 25, 2024

Primary Completion Date

December 30, 2026

Study Completion Date

November 30, 2027

Conditions
Depressive Disorder, Major
Interventions
DRUG

Seltorexant

Seltorexant will be administered orally.

DRUG

Placebo

Matching Placebo tablets will be administered orally.

DRUG

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

SSRI/SNRI will be administered orally.

Trial Locations (195)

1113

RECRUITING

Medical Center St. Naum, Sofia

1377

RECRUITING

Centre for Mental Health Prof.N.Shipkovenski EOOD, Sofia

1408

RECRUITING

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD, Sofia

1900

RECRUITING

INSA Instituto de Neurociencias San Agustín, La Plata

2000

RECRUITING

C I A P Centro de investigacion y Asistencia en Psiquiatria, Rosario

4002

RECRUITING

UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic, Plovdiv

4200

RECRUITING

Clinica El Jardin, Santiago del Estero

6003

RECRUITING

Medical Center ZaraMed, Stara Zagora

8001

RECRUITING

Mental Health Center Prof. Dr. Ivan Temkov, Burgas

8035

RECRUITING

Hosp Univ Vall D Hebron, Barcelona

9020

RECRUITING

Diagnostic Consulting Center Mladost - M Varna, Varna

10000

RECRUITING

Clintrial s r o, Prague

10017

RECRUITING

Fieve Clinical Research Inc, New York

10022

COMPLETED

Hapworth Psychiatric Medical PLLC, New York

10549

RECRUITING

Bioscience Research LLC, Mount Kisco

11000

RECRUITING

University Clinical Center of Serbia, Belgrade

RECRUITING

University Clinical Hospital Center Dr Dragisa Misovic- Dedi, Belgrade

11229

RECRUITING

Integrative Clinical Trials LLC, Brooklyn

11235

RECRUITING

SPRI Clinical Trials, LLC, Brooklyn

11797

COMPLETED

Lucian Miron Manu MD Psychiatry PC, Woodbury

12000

RECRUITING

Pragtis S R O, Prague

14202

COMPLETED

University at Buffalo Psychiatry, Buffalo

16000

RECRUITING

Medical Services Prague S R O, Prague

16059

RECRUITING

Uludag Universitesi Tıp Fakultesi Hastanesi, Bursa

16132

RECRUITING

IRCCS Aor San Martino IST, Genova

16285

RECRUITING

Bursa High Speciality Training and Research Dortcelik Mental Hospital, Bursa

18202

RECRUITING

Special Hospital for Psychiatric Diseases Gornja Toponica, Gornja Toponica

19104

RECRUITING

University of Pennsylvania, Philadelphia

20900

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

22222

RECRUITING

ProbarE i Lund AB, Lund

23330

RECRUITING

Specialized Hospital for Psychiatric Diseases Sveti Vracevi, Novi Kneževac

25123

RECRUITING

Territorial Social Health Authority of the Spedali Civili of Brescia, Brescia

26220

RECRUITING

Special Hospital for Psychiatric Diseases Kovin, Kovin

27580

RECRUITING

Gaziantep Universitesi Tip Fakultesi, Gaziantep

28031

RECRUITING

Hosp. Univ. Infanta Leonor, Madrid

28034

RECRUITING

Hospital Ramon y Cajal, Madrid

28046

RECRUITING

Hosp. Univ. La Paz, Madrid

28400

RECRUITING

Hosp. Gral. de Villalba, Collado Villalba

28601

RECRUITING

IMA Clinical Research PC, Hickory

29406

RECRUITING

Clinical Trials of South Carolina, Charleston

29425

COMPLETED

Medical University of South Carolina, Charleston

30017

RECRUITING

Accelerated Clinical Research Group LLC, Peachtree Corners

30030

RECRUITING

iResearch Atlanta LLC, Decatur

30073

RECRUITING

Specjalistyczna Praktyka Lekarska Piotr Zalitacz, Gorlice

30078

COMPLETED

Renew Health Clinical Research, Snellville

30318

RECRUITING

Advanced Discovery Research, Atlanta

30328

RECRUITING

Agile Clinical Research Trials, LLC, Atlanta

30338

COMPLETED

Peachford Hospital-Atlanta Behavorial Research, Dunwoody

31405

COMPLETED

iResearch Savannah, Savannah

32055

COMPLETED

Multi Specialty Research Associates Inc, Lake City

32086

COMPLETED

Florida Center for TMS, Saint Augustine

32256

RECRUITING

Clinical NeuroScience Solutions Inc, Jacksonville

32789

COMPLETED

Conquest Research, Winter Park

32803

RECRUITING

Nova Psychiatry INC, Orlando

33012

RECRUITING

AGA Clinical Trials, Hialeah

RECRUITING

Reliable Clinical Research, Hialeah

33033

RECRUITING

Advanced Research Institute of Miami, Homestead

33126

RECRUITING

Pharmax Research Clinic Inc, Miami

33141

RECRUITING

Bravo Health Care Center, North Bay Village

33176

RECRUITING

Miami Dade Medical Research Institute, Miami

33186

RECRUITING

Nuovida Research Center, Miami

33407

RECRUITING

Health Synergy Clinical Research, West Palm Beach

33511

RECRUITING

Clinical Research of Brandon, Brandon

33613

RECRUITING

University of South Florida, Tampa

33614

RECRUITING

Psych Me Medical Research Inc, Tampa

33629

RECRUITING

Interventional Psychiatry of Tampa Bay, Tampa

33777

COMPLETED

Alcanza Clinical Research, Largo

34105

COMPLETED

Aqualane Clinical Research, Naples

34736

RECRUITING

Erenkoy Mental Hospital, Istanbul

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

41001

RECRUITING

Kocaeli University Medical Faculty, Kocaeli

43153

RECRUITING

CTC GoCo, Mölndal

43210

RECRUITING

The Ohio State University, Columbus

44012

COMPLETED

Haidar Almhana Nieding, Avon Lake

44130

COMPLETED

North Star Medical Research, Middleburg Heights

45215

RECRUITING

Patient Priority Clinical Sites LLC, Cincinnati

45219

RECRUITING

University of Cincinnati College of Medicine, Cincinnati

48013

RECRUITING

Hosp. Univ. de Basurto, Bilbao

53100

RECRUITING

A O Universitaria Senese Ospedale Santa Maria alle Scotte, Siena

55020

RECRUITING

Liv Hospital, Samsun

56001

RECRUITING

Mankato Clinic, Mankato

56126

RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

60123

ACTIVE_NOT_RECRUITING

Revive Research Institute, Elgin

60200

RECRUITING

Medipa S R O, Brno

60563

RECRUITING

Baber Research Group, Naperville

60611

RECRUITING

Northwestern University, Chicago

60614

COMPLETED

MetroMed Clinical Research, Chicago

60637

RECRUITING

University of Chicago Medical Center, Chicago

61080

COMPLETED

Karadeniz Teknik University Medical Faculty, Trabzon

64460

RECRUITING

Hospital Universitario Dr Jose Eleuterio Gonzalez, Nuevo León

64620

RECRUITING

Centro de Estudios Clinicos y Especialidades Medicas S C, Nuevo León

64710

RECRUITING

Instituto de Informacion e Investigacion en Salud Mental A.C., Monterrey

66100

RECRUITING

Universita D Annunzio, Chieti

72022

RECRUITING

SanRo Clinical Research Group LLC WCG Clinical Network, Bryant

72211

COMPLETED

Preferred Research Partners, Little Rock

73013

RECRUITING

Conrad Clinical Research, Edmond

75041

RECRUITING

VAST Clinical Research, Garland

75237

RECRUITING

CTC MTC Uppsala, Uppsala

75243

COMPLETED

Relaro Medical Trials, Dallas

76104

RECRUITING

North Texas Clinical Trials, Fort Worth

76309

ACTIVE_NOT_RECRUITING

Grayline Research Center, Wichita Falls

77030

RECRUITING

Baylor College of Medicine, Houston

77081

RECRUITING

DM Clinical Research, Houston

77401

RECRUITING

Houston Clinical Trials LLC, Bellaire

77477

RECRUITING

R and H Clinical Research, Stafford

78218

RECRUITING

Hospital Lomas de San Luis Internacional, San Luis de Potosi

78712

RECRUITING

The University of Texas at Austin, Austin

78759

COMPLETED

BioBehavioral Research of Austin PC, Austin

80209

RECRUITING

Mountain View Clinical Research, Denver

84020

COMPLETED

Cedar Clinical Research, Draper

RECRUITING

Ospedale S Francesco d Assisi, Salerno

85224

COMPLETED

Chandler Clinical Trials, Chandler

85724

RECRUITING

University of Arizona, Tucson

89119

RECRUITING

Redbird Research, Las Vegas

89121

COMPLETED

Oasis Clinical Research LLC, Las Vegas

90720

COMPLETED

WR PRI Los Alamitos, Los Alamitos

91206

RECRUITING

Behavioral Research Specialists LLC, Glendale

91316

COMPLETED

Elite Research Network, Encino

91403

COMPLETED

California Neuroscience Research, Sherman Oaks

91730

COMPLETED

Prospective Research Innovations Inc, Rancho Cucamonga

92056

RECRUITING

Excell Research Inc, Oceanside

92324

RECRUITING

Axiom Research, Colton

92374

RECRUITING

Anderson Clinical Research, Redlands

92705

COMPLETED

Syrentis Clinical Research, Santa Ana

92801

RECRUITING

PAMOJA Clinical Institute LLC, Anaheim

95123

RECRUITING

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico, Catania

95124

RECRUITING

Lumos Clinical Research Center LLC, San Jose

98201

RECRUITING

Core Clinical Research, Everett

200157

RECRUITING

Centrul Medical Melchisedec, Craiova

400012

RECRUITING

Spitalul Clinic Judetean de Urgenta Cluj Napoca, Cluj-Napoca

410169

RECRUITING

Spitalul Clinic Judetean de Urgenta Oradea, Oradea

507190

RECRUITING

Spitalul de Psihiatrie si Neurologie Brasov, Sânpetru

550082

RECRUITING

Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda, Sibiu

620117

COMPLETED

CMI Dr. Sarpe Marcel-Claudiu, Focşani

700282

RECRUITING

Institutului Regional de Psihiatrie 'Socola' Iasi, Iași

90430001

RECRUITING

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul, Porto Alegre

90619900

RECRUITING

Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul, Porto Alegre

06030

RECRUITING

UConn Health Center, Farmington

02131

COMPLETED

Boston Clinical Trials, Boston

02472

RECRUITING

Adams Clinical LLC, Watertown

03801

COMPLETED

ActivMed Practices and Research, Portsmouth

C1133AAH

RECRUITING

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales, Buenos Aires

5000FJF

RECRUITING

CEN Consultorios Especializados en Neurociencias, Córdoba

X5003DCE

RECRUITING

Instituto Medico DAMIC, Córdoba

X5006IKK

RECRUITING

Centro Medico Luquez, Córdoba

X5009BIN

RECRUITING

Sanatorio Prof Leon S Morra S A, Córdoba

70200 730

RECRUITING

L2IP Instituto de Pesquisas Clinicas, Brasília

13087 567

RECRUITING

CAEP Centro Avancado De Estudos E Pesquisas, Campinas

88811 000

RECRUITING

Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose, Criciúma

59012 300

RECRUITING

Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes, Natal

99010 120

RECRUITING

Instituto Mederi de Pesquisa e Saude, Passo Fundo

90035 903

RECRUITING

Hospital De Clinicas De Porto Alegre, Porto Alegre

22270 060

RECRUITING

Ruschel Medicina e Pesquisa Clínica Ltda, Rio de Janeiro

09726 150

RECRUITING

Centro Integrado Facili, São Bernardo do Campo

01228 000

RECRUITING

CPQuali Pesquisa Clinica LTDA ME, São Paulo

01236 030

RECRUITING

BR Trials, São Paulo

301 00

RECRUITING

A Shine S R O, Pilsen

110 00

RECRUITING

Neuropsychiatrie Petrska sro, Prague

00168

RECRUITING

Policlinico Universitario Agostino Gemelli, Roma

03100

RECRUITING

Health Pharma Professional Research, Mexico City

04100

RECRUITING

Ketamine Mexico S de RL de C V, Mexico City

07000

RECRUITING

Gabipros SC, Mexico City

85 605

COMPLETED

Centrum Medyczne Intercor Sp z o o, Bydgoszcz

85 794

RECRUITING

Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska, Bydgoszcz

85-133

RECRUITING

PROMENTE Sp. z o.o., Bydgoszcz

80 283

RECRUITING

Centrum Zdrowia Alcea, Gdansk

86 300

RECRUITING

NZOZ Euromedica Grudziadz, Grudziądz

40 514

RECRUITING

Clinic BBP, Katowice

64-100

RECRUITING

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS, Leszno

60 192

RECRUITING

Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka, Poznan

00-774

RECRUITING

Szpital Nowowiejski Osrodek Badan Klinicznych, Warsaw

02-172

COMPLETED

MTZ Clinical Research Powered by Pratia, Warsaw

4710 243

RECRUITING

Uls Braga - Hosp. Braga, Braga

2410 197

RECRUITING

Uls Regiao Leiria - Hosp. Santo Andre, Leiria

1349 019

RECRUITING

Uls Lisboa Ocidental - Hosp. Egas Moniz, Lisbon

1400 038

RECRUITING

Fund. Champalimaud, Lisbon

1649 035

RECRUITING

Uls Santa Maria - Hosp. Santa Maria, Lisbon

2674 514

RECRUITING

Uls Loures Odivelas - Hosp. Loures, Loures

9500 370

RECRUITING

Hosp. Divino Espirito Santo Ponta Delgada, Ponta Delgada

4100 180

RECRUITING

Hosp. Cuf Porto, Porto

4480-565

COMPLETED

Hosp. Central Trofa Saude, Touguinho

041914

RECRUITING

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia, Bucharest

821 01

RECRUITING

Psychiatricka Ambulancia Mentum S.R.O., Bratislava

040 01

RECRUITING

Univerzitna nemocnica L. Pasteura Kosice, Košice

031 23

RECRUITING

Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu, Liptovský Mikuláš

979 01

RECRUITING

Psychiatricka Ambulancia Psycholine S.R.O., Rimavská Sobota

089 01

RECRUITING

Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O., Svidník

093 01

RECRUITING

Crystal Comfort s.r.o., Vranov nad Topľou

08025

RECRUITING

Institucion Hosp Hestia Palau, Barcelona

08036

RECRUITING

Hosp Clinic de Barcelona, Barcelona

03186

RECRUITING

Hosp. Univ. de Torrevieja, Torrevieja

113 29

RECRUITING

ProbarE i Stockholm AB, Stockholm

06010

RECRUITING

Gulhane Egitim ve Arastirma Hastanesi, Ankara

06620

RECRUITING

Ankara University Medical Faculty, Ankara

06800

RECRUITING

Ankara Bilkent Sehir Hastanesi, Ankara

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY