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NCT06559306PHASE3Recruiting

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

Janssen Research & Development, LLC

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

Inclusion Criteria: Participants in part 1 and direct enrollers to part 2: * Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60 * Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment * Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks * Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening. Participants entering after completing part 1: * Must have completed Part 1 DB treatment phase * Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2 * Was able to consistently follow the study procedures in Part 1 as judged by the investigator. * Must be medically stable based on clinical laboratory tests Exclusion Criteria: * Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus * Has a history of narcolepsy and seizures * Has current signs/symptoms of hypothyroidism or hyperthyroidism * Participants taking thyroid supplementation for antidepressant purposes * Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis

Interventions

DRUG

Seltorexant

DRUG

Placebo

DRUG

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

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Conditions

Depressive Disorder, Major

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)