A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

757

Participants

Timeline

Start Date

September 15, 2020

Primary Completion Date

October 3, 2023

Study Completion Date

October 3, 2023

Conditions
Depressive Disorder, Major
Interventions
DRUG

Seltorexant

Participants will receive seltorexant over-encapsulated tablet orally.

DRUG

Matching placebo to Seltorexant

Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.

DRUG

Quetiapine XR

Participants will receive quetiapine XR capsule orally.

DRUG

Matching placebo to Quetiapine XR

Participants will receive placebo capsule matching to quetiapine XR orally.

Trial Locations (175)

1030

Railway Clinical Hospital #1 of Kiev Railway station of DTGO 'South-Western Railway', Kyiv

1034

Medical Center Health and Happy, Kyiv

1113

Medical Center St. Naum, Sofia

1199

Hospital Italiano, Buenos Aires

1207

Fakultna nemocnica s poliklinikou v Ziline, Žilina

1680

Medical Center Intermedica, OOD, Sofia

1784

MC 'Synexus Sofia' EOOD, Sofia

1902

CENPIA, La Plata

4000

Clinica Mayo de UMCB, San Miguel de Tucumán

4028

MC 'Hipokrat - N', EOOD, Plovdiv

5000

Fundacion Lennox, Córdoba

Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo

5800

Medical Center Medconsult-Pleven, Pleven

6000

MC 'Synexus Sofia' EOOD, Stara Zagora

6003

UMHAT Prof. Dr. St. Kirkovich AD, Stara Zagora

7003

Mental Health Center - Rousse, Rousse

8310

AZ Sint-Lucas, Bruges

8631

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association, Hlevakha

9020

Diagnostic Consulting Center Mladost - M Varna, Varna

9100

AZ Nikolaas, Sint-Niklaas

9747

State Psychiatric Hospital - Tzarev Brod, Tzarev Brod

10000

AD71 s.r.o., Prague

10017

Fieve Clinical Research Inc, New York

10128

The Medical Research Network, LLC, New York

10204

Antakalnis Psychiatric Consultation Centre, Public Institution, Vilnius

10309

Vilnius Mental Health Center, Vilnius

10312

Richmond Behavioral Associates, Staten Island

10990

Hospital Pulau Pinang, Pulau Pinang

11000

General Hospital Acibadem Bel Medic, Belgrade

General Hospital Euromedik, Belgrade

Institute of Mental Health Serbia, Belgrade

University Clinical Center of Serbia, Belgrade

University Clinical Hospital Center Dr Dragisa Misovic- Dedi, Belgrade

11235

SPRI Clinical Trials, LLC, Brooklyn

18000

Clinical Center Nis, Niš

18503

Global Medical Institutes, Scranton

21208

Pharmasite Research, Inc., Baltimore

22903

University of Virginia, Charlottesville

23330

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi, Novi Kneževac

23801

Clinical Neuroscience Solutions, Orlando

25491

Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council', Nove

26220

Special Neuropsychiatric Hospital Kovin, Kovin

27701

Velocity Clinical Research, Inc., Durham

29464

Coastal Carolina Research Center, Mt. Pleasant

30030

iResearch Atlanta LLC, Decatur

30060

Psych Atlanta, P.C., Marietta

30328

Synexus Clinical Research US Inc, Atlanta

30331

Atlanta Center for Medical Research, Atlanta

30990

Hospital Raja Permaisuri Bainun, Ipoh

32162

Compass Research LLC-Bioclinica Research, The Villages

32806

Synexus Research Orlando, Orlando

33009

Velocity Clinical Research, Hallandale Beach, Hallandale

33012

Indago Research & Health Center Inc, Hialeah

New Life Medical Research Center, Inc., Hialeah

33013

Amedica Research Institute Inc, Hialeah

33122

Premier Clinical Research, Miami

33125

Global Medical Institutes, Miami

33137

Miami Jewish Health System, Miami

33166

Moonshine Research Center, Inc, Doral

33612

University of South Florida, Tampa

33803

Meridien Research, Lakeland

34000

University Clinical Center Kragujevac, Kragujevac

35233

University of Alabama at Birmingham, Birmingham

44720

Neuro Behavioral Clinical Research, North Canton

45219

University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience, Cincinnati

45417

Midwest Clinical Research Center, Dayton

46020

Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU, Ternopil

48259

Kaunas Silainiu Outpatient Clinic, Public Institution, Kaunas

53136

Republic Kaunas Hospital, Kaunas

53188

Cary J. Kohlenberg, MD, SC, dba, IPC Research., Waukesha

60048

Capstone Clinical Research, Libertyville

60200

Psychiatricka ambulance Saint Anne s.r.o., Brno

60532

Alexian Brothers Health System, Lisle

60563

Baber Research Group, Naperville

60618

Lemah Creek Clinical Research, Oakbrook Terrace

60634

Chicago Research Center, Chicago

61068

Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3', Kharkiv

63368

Psychiatric Care and Research Center (PCRC), O'Fallon

67214

Ascension via Christi Research, Wichita

69600

Zaporizhzhia Regional Clinical Hospital, Zaporizhzhia

70115

Riverstar Research, New Orleans

70300

Hospital Tuanku Jaafar, Seremban

73112

Sooner Clinical Research, Oklahoma City

73118

Paradigm Research Professionals, LLC, Oklahoma City

76054

Hawkins Psychiatry, PC, Mansfield

76104

North Texas Clinical Trials, Fort Worth

76309

Grayline Research Center, Wichita Falls

77381

Family Psychiatry of The Woodlands, The Woodlands

77401

West Houston Clinical Research Service, Bellaire

81200

Hospital Permai, Johor Bahru

84015

Alpine Research Organization, Clinton

84020

Cedar Clinical Research, Draper

85712

SW Biomedical Research LLC, Tucson

90025

CalNeuro Research, Los Angeles

90230

Proscience Research Group, Culver City

90660

CNRI-Los Angeles, LLC, Pico Rivera

90720

Pharmacology Research Institute, Los Alamitos

90806

Collaborative NeuroScience Network, Long Beach

91101

FN Trencin, Trenčín

91108

Pro mente sana s.r.o., Trenčín

91316

Pharmacology Research Institute, Encino

91403

Schuster Medical Research Institute, Sherman Oaks

91704

National Research Institute, Santa Ana

91730

Prospective Research Innovations Inc, Rancho Cucamonga

91786

Pacific Clinical Research Medical Group, Upland

92071

CMB Clinical Trials, Santee

92103

University of California at San Diego, San Diego

92374

Anderson Clinical Research, Redlands

92660

Pharmacology Research Institute, Newport Beach

92705

CI Trials, Santa Ana

92845

Collaborative NeuroScience Network, Garden Grove

92868

NRC Research Institute, Orange

Pacific Neuropsychiatric Specialists, Orange

97201

Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach, Bojnice

97401

Psychomed-Svatosavsky, s.r.o., Banská Bystrica

97901

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

98007

Northwest Clinical Research Center, Bellevue

98201

Core Clinical Research, Everett

99176

Medical Center Puriena JSC, Šilutė

105082

JSC Scientific Centre of Personalized Medicine, Moscow

107076

FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia, Moscow

Moscow Scientific Research Institute of Psychiatry, Moscow

192019

St-Petersburg Bekhterev Psychoneurological Research Institute, Saint Petersburg

399313

GUZ Lipetsk Regional psychoneurological Hospital #1, Lipetsk Region

413124

Engels psychiatric hospital, Engel's

620030

Sverdlov Regional Psychiatric Clinical Hospital, Yekaterinburg

634009

Klinika StoLet Ltd, Tomsk

644070

Clinical Psychiatry Hospital n.a. N.N. Solodovnikov, Omsk

650036

Kemerovo Regional Clinical Psychiatric Hospital, Kemerovo

06102

Hartford Hospital, Hartford

02740

BTC of New Bedford, New Bedford

02135

Boston Clinical Trials & Medical Research, Roslindale

08755

Bio Behavioral Health, Toms River

14618 1609

Finger Lakes Clinical Research, Rochester

08021

Suburban Research Associates, Pine Hill

1058AAJ

CENydET - Centro Neurobiologico y de Stress Traumatico, Buenos Aires

C1405BOA

FunDaMos, Buenos Aires

C1428AQK

Hospital Fleni, Ciudad Autonoma Buenos Aires

X5004AOA

Instituto Privado Kremer, Córdoba

X5006IKK

Centro Medico Luquez, Córdoba

Thanks

Clinica Privada de Salud Mental Santa Teresa de Ávila, La Plata

M5502AWY

CENAIN, Mendoza

B1P 1E1

A.K. Munshi Medical Inc., Sydney

M3J 2C5

Canadian Phase Onward, Toronto

H1M 1B1

Clinique Force Medic (GCP Trials), Montreal

500 09

NeuropsychiatrieHK, s.r.o., Hradec Králové

301 00

A Shine S R O, Pilsen

100 00

Clintrial s r o, Prague

160 00

NeuropsychiatrieHK, s.r.o., Prague

186 00

Institut Neuropsychiatricke pece, Prague

LV-3008

The Mental Hospital of Jelgava Ģintermuiža - Psychiatry, Jelgava

LV-3401

L. Keruze Practice in Psychiatry, Liepāja

LV-4601

Hospital of Rezekne, Outpatient Centre of Psychiatry

LV-1002

Riga Centre of Psychiatry and Narcology, Riga

LT-44279

Romuvos Klinika, JSC, Kaunas

LT-50009

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

09112

Zirmunai Mental Health Center, Public Institution, Vilnius

97-400

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski, Bełchatów

15-464

Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski, Bialystok

85-080

Przychodnia Srodmiescie SP. z o.o., Bydgoszcz

80 546

Centrum Badan Klinicznych PI House sp z o o, Gdansk

90-009

Specjalistyczna Indywidualna Praktyka Lekarska, Lodz

90-368

CCBR - Lodz - PL, Lodz

20-582

Specjalistyczna Praktyka Lekarska Marek Domanski, Lublin

60-702

Synexus Polska Sp. z.o.o. Oddzial w Poznaniu, Poznan

01 737

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp z o.o., Warsaw

02 957

Instytut Psychiatrii I Neurologii, Warsaw

040 11

Epamed sro, Košice

03123

Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu, Liptovský Mikuláš

04080

Kyiv Territorial Medical Incorporation 'Psychiatry', Kyiv

DE22 3LZ

Kingsway Hospital, Derby

M15 6SX

Synexus, Greater Manchester

HG1 2PW

Garden Valleys Resource Centre, Harrogate

SE5 8EF

Kings College Hospital NHS Trust, London

TR15 2SP

Cornwall Partnership Foundation Trust, Redruth

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04513912 - A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy | Biotech Hunter | Biotech Hunter