Clinical trial NCT06559306: Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
timeFrame: Baseline, Day 43
measure: Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response
timeFrame: Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)
Secondary outcomes:
measure: Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43
timeFrame: Baseline, Day 43
measure: 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
timeFrame: Baseline, Day 43
measure: Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43
timeFrame: Baseline, Day 43
measure: 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
timeFrame: From Baseline to Day 43
measure: 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
timeFrame: Baseline, Day 43
measure: Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43
timeFrame: Baseline, Day 43
measure: Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at Day 43
timeFrame: Baseline, Day 43
measure: Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Remission
timeFrame: Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)
measure: Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (8a) T-Score
timeFrame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
measure: Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (4a) T-Score
timeFrame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
measure: Part 2: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43
timeFrame: Baseline, Day 43
measure: Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in MADRS Total Score
timeFrame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
measure: Part 2: Change from Baseline to Endpoint of DB Maintenance Phase in PHQ-9 Score
timeFrame: From Baseline (Day 1 in the DB Treatment Maintenance Phase) Until End Point of the DB Maintenance Phase (that is, up to Day 337)
measure: Change From Baseline to Endpoint of the DB Maintenance Phase in the MADRS-6 score
timeFrame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
measure: Change from Baseline to Endpoint of the DB Maintenance Phase in the MADRS symptoms other than insomnia MADRS Without Sleep Item (MADRS-WOSI)
timeFrame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Bryant
country: United States
facility: SanRo Clinical Research Group LLC WCG Clinical Network
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Anaheim
country: United States
facility: PAMOJA Clinical Institute LLC
state: California
city: Colton
country: United States
facility: Axiom Research
state: California
city: Encino
country: United States
facility: Elite Research Network
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists LLC
state: California
city: Los Alamitos
country: United States
facility: WR PRI Los Alamitos
state: California
city: Oceanside
country: United States
facility: Excell Research Inc
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center LLC
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Farmington
country: United States
facility: UConn Health Center
state: Connecticut
city: Brandon
country: United States
facility: Clinical Research of Brandon
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami
state: Florida
city: Jacksonville
country: United States
facility: Clinical NeuroScience Solutions Inc
state: Florida
city: Lake City
country: United States
facility: Multi Specialty Research Associates Inc
state: Florida
city: Largo
country: United States
facility: Alcanza Clinical Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Nuovida Research Center
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: North Bay Village
country: United States
facility: Bravo Health Care Center
state: Florida
city: Orlando
country: United States
facility: Nova Psychiatry INC
state: Florida
city: Saint Augustine
country: United States
facility: Florida Center for TMS
state: Florida
city: Tampa
country: United States
facility: Psych Me Medical Research Inc
state: Florida
city: Tampa
country: United States
facility: Interventional Psychiatry of Tampa Bay
state: Florida
city: West Palm Beach
country: United States
facility: Health Synergy Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Atlanta
country: United States
facility: Advanced Discovery Research
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta LLC
state: Georgia
city: Dunwoody
country: United States
facility: Peachford Hospital-Atlanta Behavorial Research
state: Georgia
city: Peachtree Corners
country: United States
facility: Accelerated Clinical Research Group LLC
state: Georgia
city: Savannah
country: United States
facility: iResearch Savannah
state: Georgia
city: Snellville
country: United States
facility: Renew Health Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Elgin
country: United States
facility: Revive Research Institute
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical LLC
state: Massachusetts
city: Mankato
country: United States
facility: Mankato Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Redbird Research
state: Nevada
city: Las Vegas
country: United States
facility: Oasis Clinical Research LLC
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices and Research
state: New Hampshire
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Buffalo
country: United States
facility: University at Buffalo Psychiatry
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research LLC
state: New York
city: New York
country: United States
facility: Fieve Clinical Research Inc
state: New York
city: New York
country: United States
facility: Hapworth Psychiatric Medical PLLC
state: New York
city: Woodbury
country: United States
facility: Lucian Miron Manu MD Psychiatry PC
state: New York
city: Avon Lake
country: United States
facility: Haidar Almhana Nieding
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites LLC
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: BioBehavioral Research of Austin PC
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials LLC
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: Garland
country: United States
facility: VAST Clinical Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Stafford
country: United States
facility: R and H Clinical Research
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
city: Cordoba
country: Argentina
facility: CEN Consultorios Especializados en Neurociencias
city: Cordoba
country: Argentina
facility: Instituto Medico DAMIC
city: Cordoba
country: Argentina
facility: Centro Medico Luquez
city: Cordoba
country: Argentina
facility: Sanatorio Prof Leon S Morra S A
city: La Plata
country: Argentina
facility: INSA Instituto de Neurociencias San Agustín
city: Rosario
country: Argentina
facility: C I A P Centro de investigacion y Asistencia en Psiquiatria
city: Santiago del Estero
country: Argentina
facility: Clinica El Jardin
city: Brasilia
country: Brazil
facility: L2IP Instituto de Pesquisas Clinicas
city: Campinas
country: Brazil
facility: CAEP Centro Avancado De Estudos E Pesquisas
city: Criciuma
country: Brazil
facility: Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
city: Passo Fundo
country: Brazil
facility: Instituto Mederi de Pesquisa e Saude
city: Porto Alegre
country: Brazil
facility: Hospital De Clinicas De Porto Alegre
city: Porto Alegre
country: Brazil
facility: NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica Ltda
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Integrado Facili
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: Sao Paulo
country: Brazil
facility: BR Trials
city: Plovdiv
country: Bulgaria
facility: UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
city: Sofia
country: Bulgaria
facility: Medical Center St. Naum
city: Sofia
country: Bulgaria
facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center ZaraMed
city: Varna
country: Bulgaria
facility: Diagnostic Consulting Center Mladost - M Varna
city: Brescia
country: Italy
facility: Territorial Social Health Authority of the Spedali Civili of Brescia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Mexico city
country: Mexico
facility: Health Pharma Professional Research
city: Mexico city
country: Mexico
facility: Ketamine Mexico S de RL de C V
city: Mexico city
country: Mexico
facility: Gabipros SC
city: Monterrey
country: Mexico
facility: Instituto de Informacion e Investigacion en Salud Mental A.C.
city: Nuevo Leon
country: Mexico
facility: Centro de Estudios Clinicos y Especialidades Medicas S C
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Intercor Sp z o o
city: Bydgoszcz
country: Poland
facility: PROMENTE Sp. z o.o.
city: Gdansk
country: Poland
facility: Centrum Zdrowia Alcea
city: Gorlice
country: Poland
facility: Specjalistyczna Praktyka Lekarska Piotr Zalitacz
city: Grudziadz
country: Poland
facility: NZOZ Euromedica Grudziadz
city: Katowice
country: Poland
facility: Clinic BBP
city: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
city: Poznan
country: Poland
facility: Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
city: Warszawa
country: Poland
facility: Szpital Nowowiejski Osrodek Badan Klinicznych
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Braga
country: Portugal
facility: Uls Braga - Hosp. Braga
city: Lisboa
country: Portugal
facility: Uls Lisboa Ocidental - Hosp. Egas Moniz
city: Loures
country: Portugal
facility: Uls Loures Odivelas - Hosp. Loures
city: Ponta Delgada
country: Portugal
facility: Hosp. Divino Espirito Santo Ponta Delgada
city: Porto
country: Portugal
facility: Hosp. Cuf Porto
city: Touguinho
country: Portugal
facility: Hosp. Central Trofa Saude
city: Brasov
country: Romania
facility: Spitalul de Psihiatrie si Neurologie Brasov
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
city: Craiova
country: Romania
facility: Centrul Medical Melchisedec
city: Focsani
country: Romania
facility: CMI Dr. Sarpe Marcel-Claudiu
city: Sibiu
country: Romania
facility: Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Clinical Hospital Center Dr Dragisa Misovic- Dedi
city: Novi Knezevac
country: Serbia
facility: Specialized Hospital for Psychiatric Diseases Sveti Vracevi
city: Bratislava
country: Slovakia
facility: Psychiatricka Ambulancia Mentum S.R.O.
city: Kosice
country: Slovakia
facility: Univerzitna nemocnica L. Pasteura Kosice
city: Liptovsky Mikulas
country: Slovakia
facility: Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
city: Rimavska Sobota
country: Slovakia
facility: Psychiatricka Ambulancia Psycholine S.R.O.
city: Svidnik
country: Slovakia
facility: Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
city: Vranov nad Toplou
country: Slovakia
facility: Crystal Comfort s.r.o.
city: Barcelona
country: Spain
facility: Institucion Hosp Hestia Palau
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Molndal
country: Sweden
facility: CTC GoCo
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: Uppsala
country: Sweden
facility: CTC MTC Uppsala
city: Ankara
country: Turkey
facility: Gulhane Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi Tıp Fakultesi Hastanesi
city: Bursa
country: Turkey
facility: Bursa High Speciality Training and Research Dortcelik Mental Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Erenkoy Mental Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Samsun
country: Turkey
facility: Liv Hospital
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trail
role: STUDY_DIRECTOR
References: