Phase
Condition
Depression
Treatment
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Placebo
Seltorexant
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants in part 1 and direct enrollers to part 2:
Meet DSM-5 MDD, without psychotic features based upon clinical assessment andconfirmed by the structured clinical interview for DSM-5 Axis I disorders-clinicaltrials 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 someimprovement (that is, improvement greater than [>] 0%) in depressive symptomseverity with residual symptoms other than insomnia present, and overall goodtolerability, as assessed by the MGH-ATRQ, and this must include the participant'scurrent antidepressant treatment
Is receiving and tolerating well any one of the following SSRI or SNRI fordepressive symptoms at screening, in any formulation and available in theparticipating country: citalopram, duloxetine, escitalopram, fluvoxamine,fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine,desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic doselevel) 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 StructuredInterview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate aclinically 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 noadditional 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 theinvestigator.
Must be medically stable based on clinical laboratory tests
Exclusion
Exclusion Criteria:
Has a recent (last 3 months) history of, or current signs and symptoms of, severerenal insufficiency clinically significant or unstable cardiovascular, respiratory,gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrinedisorders 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 ofsignificant medical disorders of the HPA axis
Study Design
Connect with a study center
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Ciudad Autonoma de Buenos Aires, C1133AAH
ArgentinaActive - Recruiting
CEN Consultorios Especializados en Neurociencias
Cordoba, 5000FJF
ArgentinaActive - Recruiting
Centro Medico Luquez
Cordoba, X5006IKK
ArgentinaActive - Recruiting
Instituto Medico DAMIC
Cordoba, X5003DCE
ArgentinaActive - Recruiting
Sanatorio Prof Leon S Morra S A
Cordoba, X5009BIN
ArgentinaActive - Recruiting
INSA Instituto de Neurociencias San Agustín
La Plata, 1900
ArgentinaActive - Recruiting
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, 2000
ArgentinaActive - Recruiting
Clinica El Jardin
Santiago del Estero, 4200
ArgentinaActive - Recruiting
L2IP Instituto de Pesquisas Clinicas
Brasilia, 70200 730
BrazilActive - Recruiting
CAEP Centro Avancado De Estudos E Pesquisas
Campinas, 13087 567
BrazilActive - Recruiting
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciuma, 88811 000
BrazilActive - Recruiting
Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
Natal, 59012 300
BrazilActive - Recruiting
Instituto Mederi de Pesquisa e Saude
Passo Fundo, 99010 120
BrazilActive - Recruiting
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903
BrazilActive - Recruiting
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, 90430001
BrazilActive - Recruiting
Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, 90619900
BrazilActive - Recruiting
Ruschel Medicina e Pesquisa Clínica Ltda
Rio de Janeiro, 22270 060
BrazilActive - Recruiting
Centro Integrado Facili
Sao Bernardo do Campo, 09726 150
BrazilActive - Recruiting
BR Trials
Sao Paulo, 01236 030
BrazilActive - Recruiting
CPQuali Pesquisa Clinica LTDA ME
Sao Paulo, 01228 000
BrazilActive - Recruiting
UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
Plovdiv, 4002
BulgariaActive - Recruiting
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, 1408
BulgariaActive - Recruiting
Medical Center St. Naum
Sofia, 1113
BulgariaActive - Recruiting
Medical Center ZaraMed
Stara Zagora, 6003
BulgariaActive - Recruiting
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020
BulgariaActive - Recruiting
Territorial Social Health Authority of the Spedali Civili of Brescia
Brescia, 25123
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
ItalyActive - Recruiting
Gabipros SC
Mexico city, 07000
MexicoActive - Recruiting
Health Pharma Professional Research
Mexico city, 03100
MexicoActive - Recruiting
Ketamine Mexico S de RL de C V
Mexico city, 04100
MexicoActive - Recruiting
Instituto de Informacion e Investigacion en Salud Mental A.C.
Monterrey, 64710
MexicoActive - Recruiting
Centro de Estudios Clinicos y Especialidades Medicas S C
Nuevo Leon, 64620
MexicoActive - Recruiting
Centrum Medyczne Intercor Sp z o o
Bydgoszcz, 85 605
PolandActive - Recruiting
PROMENTE Sp. z o.o.
Bydgoszcz, 85-133
PolandActive - Recruiting
Centrum Zdrowia Alcea
Gdansk, 80 283
PolandActive - Recruiting
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Gorlice, 30073
PolandActive - Recruiting
NZOZ Euromedica Grudziadz
Grudziadz, 86 300
PolandActive - Recruiting
Clinic BBP
Katowice, 40 514
PolandActive - Recruiting
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100
PolandActive - Recruiting
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Poznan, 60 192
PolandActive - Recruiting
MTZ Clinical Research Powered by Pratia
Warszawa, 02-172
PolandActive - Recruiting
Szpital Nowowiejski Osrodek Badan Klinicznych
Warszawa, 00-774
PolandActive - Recruiting
Uls Braga - Hosp. Braga
Braga, 4710 243
PortugalActive - Recruiting
Uls Lisboa Ocidental - Hosp. Egas Moniz
Lisboa, 1349 019
PortugalActive - Recruiting
Uls Loures Odivelas - Hosp. Loures
Loures, 2674 514
PortugalActive - Recruiting
Hosp. Divino Espirito Santo Ponta Delgada
Ponta Delgada, 9500 370
PortugalActive - Recruiting
Hosp. Cuf Porto
Porto, 4100 180
PortugalActive - Recruiting
Hosp. Central Trofa Saude
Touguinho, 4480-565
PortugalActive - Recruiting
Spitalul de Psihiatrie si Neurologie Brasov
Brasov, 500123
RomaniaActive - Recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucuresti, 041914
RomaniaActive - Recruiting
Centrul Medical Melchisedec
Craiova, 200157
RomaniaActive - Recruiting
CMI Dr. Sarpe Marcel-Claudiu
Focsani, 620117
RomaniaActive - Recruiting
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, 550082
RomaniaActive - Recruiting
University Clinical Center of Serbia
Belgrade, 11000
SerbiaActive - Recruiting
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
Belgrade, 11000
SerbiaActive - Recruiting
Specialized Hospital for Psychiatric Diseases Sveti Vracevi
Novi Knezevac, 23330
SerbiaActive - Recruiting
Psychiatricka Ambulancia Mentum S.R.O.
Bratislava, 821 01
SlovakiaActive - Recruiting
Univerzitna nemocnica L. Pasteura Kosice
Kosice, 040 01
SlovakiaActive - Recruiting
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
Liptovsky Mikulas, 031 23
SlovakiaActive - Recruiting
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavska Sobota, 979 01
SlovakiaActive - Recruiting
Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
Svidnik, 089 01
SlovakiaActive - Recruiting
Crystal Comfort s.r.o.
Vranov nad Toplou, 093 01
SlovakiaActive - Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 8035
SpainActive - Recruiting
Institucion Hosp Hestia Palau
Barcelona, 08025
SpainActive - Recruiting
Hosp. Univ. de Basurto
Bilbao, 48013
SpainActive - Recruiting
Hosp. Univ. La Paz
Madrid, 28046
SpainActive - Recruiting
ProbarE i Lund AB
Lund, 22222
SwedenActive - Recruiting
CTC GoCo
Molndal, 43153
SwedenActive - Recruiting
ProbarE i Stockholm AB
Stockholm, 113 29
SwedenActive - Recruiting
CTC MTC Uppsala
Uppsala, 75237
SwedenActive - Recruiting
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
TurkeyActive - Recruiting
Ankara University Medical Faculty
Ankara, 06620
TurkeyActive - Recruiting
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010
TurkeyActive - Recruiting
Bursa High Speciality Training and Research Dortcelik Mental Hospital
Bursa, 16285
TurkeyActive - Recruiting
Uludag Universitesi Tıp Fakultesi Hastanesi
Bursa, 16059
TurkeyActive - Recruiting
Gaziantep Universitesi Tip Fakultesi
Gaziantep, 27580
TurkeyActive - Recruiting
Erenkoy Mental Hospital
Istanbul, 34736
TurkeyActive - Recruiting
Kocaeli University Medical Faculty
Kocaeli, 41001
TurkeyActive - Recruiting
Liv Hospital
Samsun, 55020
TurkeyActive - Recruiting
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
TurkeyActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesActive - Recruiting
Chandler Clinical Trials
Chandler, Arizona 85224
United StatesActive - Recruiting
University of Arizona
Tucson, Arizona 85724
United StatesActive - Recruiting
SanRo Clinical Research Group LLC WCG Clinical Network
Bryant, Arkansas 72022
United StatesActive - Recruiting
Preferred Research Partners
Little Rock, Arkansas 72211
United StatesTerminated
PAMOJA Clinical Institute LLC
Anaheim, California 92801
United StatesActive - Recruiting
Axiom Research
Colton, California 92324
United StatesActive - Recruiting
Elite Research Network
Encino, California 91316
United StatesActive - Recruiting
Behavioral Research Specialists LLC
Glendale, California 91206
United StatesActive - Recruiting
WR PRI Los Alamitos
Los Alamitos, California 90720
United StatesActive - Recruiting
Excell Research Inc
Oceanside, California 92056
United StatesActive - Recruiting
Prospective Research Innovations Inc
Rancho Cucamonga, California 91730
United StatesTerminated
Anderson Clinical Research
Redlands, California 92374
United StatesActive - Recruiting
Lumos Clinical Research Center LLC
San Jose, California 95124
United StatesActive - Recruiting
Syrentis Clinical Research
Santa Ana, California 92705
United StatesActive - Recruiting
California Neuroscience Research
Sherman Oaks, California 91403
United StatesActive - Recruiting
Mountain View Clinical Research
Denver, Colorado 80209
United StatesActive - Recruiting
UConn Health Center
Farmington, Connecticut 06030
United StatesActive - Recruiting
Clinical Research of Brandon
Brandon, Florida 33511
United StatesActive - Recruiting
AGA Clinical Trials
Hialeah, Florida 33012
United StatesActive - Recruiting
Reliable Clinical Research
Hialeah, Florida 33012
United StatesActive - Recruiting
Advanced Research Institute of Miami
Homestead, Florida 33030
United StatesActive - Recruiting
Clinical NeuroScience Solutions Inc
Jacksonville, Florida 32256
United StatesActive - Recruiting
Multi Specialty Research Associates Inc
Lake City, Florida 32055
United StatesActive - Recruiting
Alcanza Clinical Research
Largo, Florida 33777
United StatesActive - Recruiting
Miami Dade Medical Research Institute
Miami, Florida 33176
United StatesActive - Recruiting
Nuovida Research Center
Miami, Florida 33186
United StatesActive - Recruiting
Pharmax Research Clinic Inc
Miami, Florida 33126
United StatesActive - Recruiting
Aqualane Clinical Research
Naples, Florida 34105
United StatesActive - Recruiting
Bravo Health Care Center
North Bay Village, Florida 33141
United StatesActive - Recruiting
Nova Psychiatry INC
Orlando, Florida 32803
United StatesActive - Recruiting
Florida Center for TMS
Saint Augustine, Florida 32086
United StatesActive - Recruiting
Interventional Psychiatry of Tampa Bay
Tampa, Florida 33629
United StatesActive - Recruiting
Psych Me Medical Research Inc
Tampa, Florida 33614
United StatesActive - Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida 33407
United StatesActive - Recruiting
Conquest Research
Winter Park, Florida 32789
United StatesActive - Recruiting
Advanced Discovery Research
Atlanta, Georgia 30318
United StatesActive - Recruiting
Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328
United StatesActive - Recruiting
iResearch Atlanta LLC
Decatur, Georgia 30030
United StatesActive - Recruiting
Peachford Hospital-Atlanta Behavorial Research
Dunwoody, Georgia 30338
United StatesActive - Recruiting
Accelerated Clinical Research Group LLC
Peachtree Corners, Georgia 30017
United StatesActive - Recruiting
iResearch Savannah
Savannah, Georgia 31405
United StatesActive - Recruiting
Renew Health Clinical Research
Snellville, Georgia 30078
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Revive Research Institute
Elgin, Illinois 60123
United StatesActive - Recruiting
Baber Research Group
Naperville, Illinois 60563
United StatesActive - Recruiting
Boston Clinical Trials
Boston, Massachusetts 02131
United StatesActive - Recruiting
Adams Clinical LLC
Watertown, Massachusetts 02472
United StatesActive - Recruiting
Mankato Clinic
Mankato, Minnesota 56001
United StatesActive - Recruiting
Oasis Clinical Research LLC
Las Vegas, Nevada 89121
United StatesActive - Recruiting
Redbird Research
Las Vegas, Nevada 89119
United StatesActive - Recruiting
ActivMed Practices and Research
Portsmouth, New Hampshire 03801
United StatesActive - Recruiting
Integrative Clinical Trials LLC
Brooklyn, New York 11229
United StatesActive - Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York 11235
United StatesActive - Recruiting
University at Buffalo Psychiatry
Buffalo, New York 14202
United StatesActive - Recruiting
Bioscience Research LLC
Mount Kisco, New York 10549
United StatesActive - Recruiting
Fieve Clinical Research Inc
New York, New York 10017
United StatesActive - Recruiting
Hapworth Psychiatric Medical PLLC
New York, New York 10022
United StatesActive - Recruiting
Lucian Miron Manu MD Psychiatry PC
Woodbury, New York 11797
United StatesActive - Recruiting
Haidar Almhana Nieding
Avon Lake, Ohio 44012
United StatesActive - Recruiting
Patient Priority Clinical Sites LLC
Cincinnati, Ohio 45215
United StatesActive - Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio 45219
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
North Star Medical Research
Middleburg Heights, Ohio 44130
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Clinical Trials of South Carolina
Charleston, South Carolina 29406
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
BioBehavioral Research of Austin PC
Austin, Texas 78759
United StatesActive - Recruiting
Houston Clinical Trials LLC
Bellaire, Texas 77401
United StatesActive - Recruiting
Relaro Medical Trials
Dallas, Texas 75243
United StatesActive - Recruiting
North Texas Clinical Trials
Fort Worth, Texas 76104
United StatesActive - Recruiting
VAST Clinical Research
Garland, Texas 75041
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
DM Clinical Research
Houston, Texas 77081
United StatesActive - Recruiting
R and H Clinical Research
Stafford, Texas 77477
United StatesActive - Recruiting
Grayline Research Center
Wichita Falls, Texas 76309
United StatesActive - Recruiting
Cedar Clinical Research
Draper, Utah 84020
United StatesActive - Recruiting
Core Clinical Research
Everett, Washington 98201
United StatesActive - Recruiting
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