A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant

PHASE3CompletedINTERVENTIONAL
Enrollment

588

Participants

Timeline

Start Date

September 16, 2020

Primary Completion Date

April 25, 2023

Study Completion Date

April 30, 2024

Conditions
Depressive Disorder, Major
Interventions
DRUG

Seltorexant

Seltorexant tablet will be administered orally once daily.

DRUG

Placebo

Matching placebo tablet will be administered orally once daily.

Trial Locations (122)

110

Taipei Medical University, Taipei

112

Cheng Hsin General Hospital, Taipei

Taipei Veterans General Hospital, Taipei

204

Chang-Gung Memorial Hospital-Keelung, Keelung

1113

Medical Center St. Naum, Sofia

1202

MHC - Sofia, EOOD, Slivnitsa

1408

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

1680

Medical Center Intermedica, OOD, Sofia

1739

DJW Research, Krugersdorp

3000

Mental Health Center - Vratsa EOOD, Vratsa

4000

Medical center Spectar - Plovdiv EOOD, Plovdiv

UMHAT 'Sv. Georgi' EAD, Plovdiv

5980

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET, Cherven Bryag

6600

State Psychiatric Hospital Kardzhali, Kardzhali

7140

Somerset West Clinical Research Unit, Strand

7530

Cape Town Clinical Research Centre, Cape Town

Flexivest 14 Research, Cape Town

7700

Medical center - VAS OOD, Targovishte

8001

Mental Health Center Prof. Dr. Ivan Temkov, Burgas

9301

Farmovs Pty Ltd, Bloemfontein

9324

Iatros International, Bloemfontein

10000

Clintrial s r o, Prague

10002

National Taiwan University Hospital, Taipei

10449

Mackay Memorial Hospital, Taipei

10549

Bioscience Research LLC, Mount Kisco

11432

Synexus Clinical Research US Inc, Jamaica

16000

Medical Services Prague S R O, Prague

18104

Lehigh Center for Clinical Research, Allentown

19104

University of Pennsylvania - Perelman School of Medicine, Philadelphia

21152

PharmaSite, Malmo

22222

ProbarE i Lund AB, Lund

25220

PharmaSite Helsingborg, Helsingborg

27201

BRAIN-SOULTHERAPY s.r.o., Kladno

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28046

Hosp. Univ. La Paz, Madrid

31008

Clinica Univ. de Navarra, Pamplona

31200

A Shine S R O, Pilsen

32256

Clinical NeuroScience Solutions Inc, Jacksonville

32607

Sarkis Clinical Trials, Gainesville

32803

APG Research LLC, Orlando

Combined Research Orlando, Orlando

Nova Psychiatry INC, Orlando

33011

Centro Salud Mental La Corredoria, Oviedo

33126

Pharmax Research Clinic Inc, Miami

33134

Medical Research Center of Miami II Inc, Miami

33141

Bravo Health Care Center, North Bay Village

33165

Phoenix Medical Research, Inc., Miami

33166

Galiz Research, Miami Springs

33305

Chang Gung Memorial Hospital- Linkou, Taoyuan

37005

Centro de salud San Juan - IBSAL, Salamanca

43221

The Ohio State University, Columbus

44012

Haidar Almhana Nieding, Avon Lake

45040

Lindner Center of Hope, Mason

48013

Hosp. Univ. de Basurto, Bilbao

48302

Neurobehavioral Medicine Group, Bloomfield Hills

49021

Hosp. Prov. de Zamora, Zamora

54143

Läkarmottagningen, Skövde

60123

Revive Research Institute, Elgin

60435

Joliet Center for Clinical Research, Joliet

60523

American Medical Research, Inc., Oak Brook

60563

Baber Research Group, Naperville

62701

Southern Illinois University School of Medicine, Springfield

63109

Mid-America Clinical Research, LLC, St Louis

63128

PsychCare Consultants Research, St Louis

63301

Midwest Research Group - St. Charles Psychiatric Associates, Saint Charles

64060

CRI Centro Regiomontano de Investigacion SC, Nuevo León

64310

Iecsi S.C., Monterrey

68526

Premier Psychiatric Research Institute, LLC, Lincoln

71101

Louisiana Clinical Research, Shreveport

73112

Oklahoma Clinical Research Center, Oklahoma City

75243

Relaro Medical Trials, Dallas

76104

North Texas Clinical Trials, Fort Worth

77030

Baylor College of Medicine, Houston

77090

Red Oak Psychiatry Associates, Houston

78213

Bind Investigaciones S.C., San Luis Potosí City

84015

Alpine Research Organization, Clinton

89102

Altea Research Institute, Las Vegas

90048

Semel Institute for Neuroscience and Human Behavior, Los Angeles

90631

Omega Clinical Trials LLC, La Habra

90703

Synexus, Cerritos

91763

Catalina Research Institute, Montclair

91945

Synergy East, Lemon Grove

92056

North County Clinical Research, Oceanside

92591

Viking Pharmaceutical Trials Inc. dba Viking Clinical Research, Temecula

92614

Irvine Clinical Research, Irvine

92705

Syrentis Clinical Research, Santa Ana

92805

Advanced Research Center Inc, Anaheim

94607

Pacific Research Partners, Oakland

111166

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda., Bogotá

150003

Yaroslavl Region Clinical Psychiatric Hospital, Yaroslavl

190013

Psychoneurological Dispensary of Frunzensky District, Saint Petersburg

190020

SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)', Saint Petersburg

190121

City Psychiatric Hospital of St. Nikolay Chudotvorets, Saint Petersburg

192019

Bekhterev Psychoneurological Research Institute, Saint Petersburg

St-Petersburg Bekhterev Psychoneurological Research Institute, Saint Petersburg

199106

Psychoneurological dispensary 1, Saint Petersburg

357034

Stavropol Region Psychiatric Hospital #2, Stavropol

06416

Connecticut Clinical Trials LLC, Cromwell

06030

University of Connecticut Health Center, Farmington

02472

Adams Clinical, Watertown

08009

Hassman Research Institute, LLC., Berlin

05701

Green Mountain Research Institute, Rutland

30150-270

CPN - Centro de Pesquisa em Neurociências Ltda, Belo Horizonte

70200-730

CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia, Brasília

81210-310

Instituto de Neurologia de Curitiba, Curitiba

60430-380

Universidade Federal do Ceara Hospital Universitario Walter Cantidio, Fortaleza

99010-120

Instituto Mederi de Pesquisa e Saude, Passo Fundo

22270 060

Ruschel Medicina e Pesquisa Clínica Ltda, Rio de Janeiro

04037-003

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo, São Paulo

13970-905

Instituto Bairral de Psiquiatria, São Paulo

Unknown

Centro de Investigaciones y Proyectos en Neurociencias CIPNA, Barranquilla

Fundacion Centro de Investigacion Clinica CIC, Medellín

Psynapsis Salud Mental S.A., Pereira

Synexus Watermeyer, Pretoria

051053

HOMO - ESE Hospital Mental de Antioquia, Bello

284 01

Neuroterapie KH S R O, Kutná Hora

0122

Stanza Clinical Research Centre : Mamelodi, Mamelodi East

08025

Institucion Hosp Hestia Palau, Barcelona

08035

Hosp Univ Vall D Hebron, Barcelona

08208

Corporacio Sanitari Parc Tauli, Sabadell

SE-30248

Affecta Pskyiatrimottagning, Halmstad

111 37

ProbarE i Solna, Stockholm

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04533529 - A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant | Biotech Hunter | Biotech Hunter