Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
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
2 other identifiers
interventional
752
15 countries
201
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2024
CompletedFirst Submitted
Initial submission to the registry
August 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
April 13, 2026
April 1, 2026
2.4 years
August 15, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Baseline, Day 43
Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response
Stable response is defined as a greater than equal to (\>=) 50 percent (%) reduction in the MADRS total score for the last 3 consecutive visits of the OL stabilization Phase, as assessed by the site investigator. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve a stable response at the end of OL seltorexant treatment will be reported.
Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)
Secondary Outcomes (15)
Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43
Baseline, Day 43
Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score at Day 43
Baseline, Day 43
Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43
Baseline, Day 43
Part 1: Percentage of Participants with Response on Depressive Symptoms Scale Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total score From Baseline to Day 43
From Baseline to Day 43
Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (4a) T-score at Day 43
Baseline, Day 43
- +10 more secondary outcomes
Study Arms (5)
Part 1: Seltorexant
EXPERIMENTALParticipants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.
Part 1: Placebo
PLACEBO COMPARATORParticipants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Part 2: Open Label (OL) Seltorexant
EXPERIMENTALAll participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.
Part 2: DB Seltorexant
EXPERIMENTALAll participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Part 2: DB Placebo
PLACEBO COMPARATORAll participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Interventions
SSRI/SNRI will be administered orally.
Seltorexant will be administered orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (205)
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, X5006IKK, 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, 6003, 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
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trail
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2024
First Posted
August 19, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www janssen, com/clinical-trialsitransparency. As noted on this site, requests for access to the study data can be submitted through 'Yale Open Data Access (YODA) Project site at yoda yale.edu