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RECRUITING
NCT06559306
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

752

Start Date

2024-07-25

Completion Date

2026-12-30

Last Updated

2026-03-13

Healthy Volunteers

No

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.

Locations (200)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

University of Arizona

Tucson, Arizona, United States

SanRo Clinical Research Group LLC WCG Clinical Network

Bryant, Arkansas, United States

Preferred Research Partners

Little Rock, Arkansas, United States

PAMOJA Clinical Institute LLC

Anaheim, California, United States

Axiom Research

Colton, California, United States

Elite Research Network

Encino, California, United States

Behavioral Research Specialists LLC

Glendale, California, United States

WR PRI Los Alamitos

Los Alamitos, California, United States

Excell Research Inc

Oceanside, California, United States

Prospective Research Innovations Inc

Rancho Cucamonga, California, United States

Anderson Clinical Research

Redlands, California, United States

Lumos Clinical Research Center LLC

San Jose, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

California Neuroscience Research

Sherman Oaks, California, United States

Mountain View Clinical Research

Denver, Colorado, United States

UConn Health Center

Farmington, Connecticut, United States

Clinical Research of Brandon

Brandon, Florida, United States

AGA Clinical Trials

Hialeah, Florida, United States

Reliable Clinical Research

Hialeah, Florida, United States

Advanced Research Institute of Miami

Homestead, Florida, United States

Clinical NeuroScience Solutions Inc

Jacksonville, Florida, United States

Multi Specialty Research Associates Inc

Lake City, Florida, United States

Alcanza Clinical Research

Largo, Florida, United States

Pharmax Research Clinic Inc

Miami, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

Nuovida Research Center

Miami, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Bravo Health Care Center

North Bay Village, Florida, United States

Nova Psychiatry INC

Orlando, Florida, United States

Florida Center for TMS

Saint Augustine, Florida, United States

University of South Florida

Tampa, Florida, United States

Psych Me Medical Research Inc

Tampa, Florida, United States

Interventional Psychiatry of Tampa Bay

Tampa, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Conquest Research

Winter Park, Florida, United States

Advanced Discovery Research

Atlanta, Georgia, United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

iResearch Atlanta LLC

Decatur, Georgia, United States

Peachford Hospital-Atlanta Behavorial Research

Dunwoody, Georgia, United States

iResearch Savannah

Savannah, Georgia, United States

Accelerated Clinical Research Group LLC

Snellville, Georgia, United States

Renew Health Clinical Research

Snellville, Georgia, United States

Northwestern University

Chicago, Illinois, United States

MetroMed Clinical Research

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Revive Research Institute

Elgin, Illinois, United States

Baber Research Group

Naperville, Illinois, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Adams Clinical LLC

Watertown, Massachusetts, United States

Mankato Clinic

Mankato, Minnesota, United States

Redbird Research

Las Vegas, Nevada, United States

Oasis Clinical Research LLC

Las Vegas, Nevada, United States

ActivMed Practices and Research

Portsmouth, New Hampshire, United States

Integrative Clinical Trials LLC

Brooklyn, New York, United States

SPRI Clinical Trials, LLC

Brooklyn, New York, United States

University at Buffalo Psychiatry

Buffalo, New York, United States

Bioscience Research LLC

Mount Kisco, New York, United States

Fieve Clinical Research Inc

New York, New York, United States

Hapworth Psychiatric Medical PLLC

New York, New York, United States

Lucian Miron Manu MD Psychiatry PC

Woodbury, New York, United States

IMA Clinical Research PC

Hickory, North Carolina, United States

Haidar Almhana Nieding

Avon Lake, Ohio, United States

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

North Star Medical Research

Middleburg Heights, Ohio, United States

Conrad Clinical Research

Edmond, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

The University of Texas at Austin

Austin, Texas, United States

BioBehavioral Research of Austin PC

Austin, Texas, United States

Houston Clinical Trials LLC

Bellaire, Texas, United States

Relaro Medical Trials

Dallas, Texas, United States

North Texas Clinical Trials

Fort Worth, Texas, United States

VAST Clinical Research

Garland, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

DM Clinical Research

Houston, Texas, United States

R and H Clinical Research

Stafford, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Cedar Clinical Research

Draper, Utah, United States

Core Clinical Research

Everett, Washington, United States

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, Argentina

CEN Consultorios Especializados en Neurociencias

Córdoba, Argentina

Instituto Medico DAMIC

Córdoba, Argentina

Centro Medico Luquez

Córdoba, Argentina

Sanatorio Prof Leon S Morra S A

Córdoba, Argentina

INSA Instituto de Neurociencias San Agustín

La Plata, Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, Argentina

Clinica El Jardin

Santiago del Estero, Argentina

L2IP Instituto de Pesquisas Clinicas

Brasília, Brazil

CAEP Centro Avancado De Estudos E Pesquisas

Campinas, Brazil

Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose

Criciúma, Brazil

Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes

Natal, Brazil

Instituto Mederi de Pesquisa e Saude

Passo Fundo, Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, Brazil

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, Brazil

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

Porto Alegre, Brazil

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, Brazil

Centro Integrado Facili

São Bernardo do Campo, Brazil

CPQuali Pesquisa Clinica LTDA ME

São Paulo, Brazil

BR Trials

São Paulo, Brazil

Mental Health Center Prof. Dr. Ivan Temkov

Burgas, Bulgaria

UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic

Plovdiv, Bulgaria

Medical Center St. Naum

Sofia, Bulgaria

Centre for Mental Health Prof.N.Shipkovenski EOOD

Sofia, Bulgaria

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

Sofia, Bulgaria

Medical Center ZaraMed

Stara Zagora, Bulgaria

Diagnostic Consulting Center Mladost - M Varna

Varna, Bulgaria

HOMO - ESE Hospital Mental de Antioquia

Bello, Colombia

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

Bogotá, Colombia

Psynapsis Salud Mental S.A.

Pereira, Colombia

Medipa S R O

Brno, Czechia

A Shine S R O

Pilsen, Czechia

Clintrial s r o

Prague, Czechia

Neuropsychiatrie Petrska sro

Prague, Czechia

Pragtis S R O

Prague, Czechia

Medical Services Prague S R O

Prague, Czechia

Territorial Social Health Authority of the Spedali Civili of Brescia

Brescia, Italy

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Catania, Italy

Universita D Annunzio

Chieti, Italy

IRCCS Aor San Martino IST

Genova, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Azienda Ospedaliera Sant Andrea

Roma, Italy

Ospedale S Francesco d Assisi

Salerno, Italy

A O Universitaria Senese Ospedale Santa Maria alle Scotte

Siena, Italy

Health Pharma Professional Research

Mexico City, Mexico

Ketamine Mexico S de RL de C V

Mexico City, Mexico

Gabipros SC

Mexico City, Mexico

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

Monterrey, Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Nuevo León, Mexico

Centro de Estudios Clinicos y Especialidades Medicas S C

Nuevo León, Mexico

Hospital Lomas de San Luis Internacional

San Luis de Potosi, Mexico

Centrum Medyczne Intercor Sp z o o

Bydgoszcz, Poland

Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska

Bydgoszcz, Poland

PROMENTE Sp. z o.o.

Bydgoszcz, Poland

Centrum Zdrowia Alcea

Gdansk, Poland

Specjalistyczna Praktyka Lekarska Piotr Zalitacz

Gorlice, Poland

Przychodnie Grudziadz sp. z o.o.

Grudziądz, Poland

Clinic BBP

Katowice, Poland

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, Poland

Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka

Poznan, Poland

Szpital Nowowiejski Osrodek Badan Klinicznych

Warsaw, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Uls Braga - Hosp. Braga

Braga, Portugal

Uls Regiao Leiria - Hosp. Santo Andre

Leiria, Portugal

Uls Lisboa Ocidental - Hosp. Egas Moniz

Lisbon, Portugal

Fund. Champalimaud

Lisbon, Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, Portugal

Uls Loures Odivelas - Hosp. Loures

Loures, Portugal

Hosp. Divino Espirito Santo Ponta Delgada

Ponta Delgada, Portugal

Hosp. Cuf Porto

Porto, Portugal

Hosp. Central Trofa Saude

Touguinho, Portugal

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

Bucharest, Romania

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

Bucharest, Romania

Spitalul Clinic Judetean de Urgenta Cluj Napoca

Cluj-Napoca, Romania

Centrul Medical Melchisedec

Craiova, Romania

CMI Dr. Sarpe Marcel-Claudiu

Focşani, Romania

Institutului Regional de Psihiatrie 'Socola' Iasi

Iași, Romania

Spitalul Clinic Judetean de Urgenta Oradea

Oradea, Romania

Spitalul de Psihiatrie si Neurologie Brasov

Sânpetru, Romania

Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda

Sibiu, Romania

University Clinical Center of Serbia

Belgrade, Serbia

University Clinical Hospital Center Dr Dragisa Misovic- Dedi

Belgrade, Serbia

Special Hospital for Psychiatric Diseases Gornja Toponica

Gornja Toponica, Serbia

Special Hospital for Psychiatric Diseases Kovin

Kovin, Serbia

Specialized Hospital for Psychiatric Diseases Sveti Vracevi

Novi Kneževac, Serbia

Psychiatricka Ambulancia Mentum S.R.O.

Bratislava, Slovakia

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu

Liptovský Mikuláš, Slovakia

Psychiatricka Ambulancia Psycholine S.R.O.

Rimavská Sobota, Slovakia

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

Svidník, Slovakia

Crystal Comfort s.r.o.

Vranov nad Topľou, Slovakia

Institucion Hosp Hestia Palau

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Univ. de Basurto

Bilbao, Spain

Hosp. Gral. de Villalba

Collado Villalba, Spain

Hosp. Univ. Infanta Leonor

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Univ. de Torrevieja

Torrevieja, Spain

ProbarE i Lund AB

Lund, Sweden

CTC GoCo

Mölndal, Sweden

ProbarE i Stockholm AB

Stockholm, Sweden

CTC MTC Uppsala

Uppsala, Sweden

Gulhane Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Uludag Universitesi Tıp Fakultesi Hastanesi

Bursa, Turkey (Türkiye)

Bursa High Speciality Training and Research Dortcelik Mental Hospital

Bursa, Turkey (Türkiye)

Gaziantep Universitesi Tip Fakultesi

Gaziantep, Turkey (Türkiye)

Erenkoy Mental Hospital

Istanbul, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Liv Hospital

Samsun, Turkey (Türkiye)

Karadeniz Teknik University Medical Faculty

Trabzon, Turkey (Türkiye)