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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
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
2029-05-04
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Seltorexant
Seltorexant will be administered orally.
Placebo
Matching Placebo tablets will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
SSRI/SNRI will be administered orally.
Locations (205)
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 6
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 3
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