Phase
Condition
Depression
Treatment
Esketamine Nasal Spray
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Based on the prior study the participant is entering 54135419TRD3008 from: a) FromESKETINTRD3001 (NCT02417064) or ESKETINTRD3002 (NCT02418585) study: Participant hascompleted the induction phase and the 2-weeks follow up phase visit; or Participantscompleted the induction phase and was a responder and study ESKETINTRD3003 isterminated.; b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsedduring the maintenance phase; or (2) Participant was in the induction phase of theESKETINTRD3003 study when the study was terminated and, after completion of theinduction phase, was determined to be a responder; or (3) Participant was in theoptimization or maintenance phases at the time the study was terminated; or (4) or (5) Participants was in the induction phase and after completion of induction phasewas determined to not meet response criteria (1) Participant completedESKETINTRD3004 study (optimization/maintenance phase); or (2) Participant was in theinduction phase of the ESKETINTRD3004 study when the study was terminated and, aftercompletion of the induction phase, was determined to be a responder; or (3)Participant was in the optimization/maintenance phase at the time the study wasterminated; (4) Participant was in the induction phase and did not meet criteria forresponse may be eligible for to be rolled over into 54135419TRD3008. d) FromESKETINTRD3005 (NCT02422186) study: Participant was in the induction phase of theESKETINTRD3005 study at the time enrollment into the ESKETINTRD3004 study was closedand, after completion of the induction phase, was determined to be a responder ordid not meet the criteria for response. e) From ESKETINTRD3006 study (US Study sitesonly) (1) Participant completed the induction phase and was a responder.
Participant must be medically stable on the basis of physical examination, vitalsigns, pulse oximetry, and 12-lead Electrocardiogram (ECG) performed predose on theday of the first intranasal treatment session. If there are any abnormalities thatare not specified in the inclusion and exclusion criteria, their clinicalsignificance must be determined by the investigator and recorded in theparticipant's source documents and initialed by the investigator
Participant must be medically stable according to the investigator's judgment andknowledge of the subject's medical stability in the parent study. This determinationmust be documented.
A woman of childbearing potential must have a negative serum (beta-human chorionicgonadotropin [b-hCG]) predose on the day of the first intranasal treatment session
During the study (that is, from the first intranasal treatment session) and for aminimum of 1 spermatogenesis cycle (defined as approximately 90 days) afterreceiving the last dose of intranasal study medication, a man who is sexually activewith a woman of childbearing potential must be practicing a highly effective methodof contraception with his female partner c) must agree not to donate sperm.
Exclusion
Exclusion Criteria:
The evaluation of the benefit versus risk of continued esketamine nasal spraytreatment is not favorable for the participant in the opinion of the investigator
Since the last study visit in the participant's prior study, participant hassuicidal ideation with intent to act per the investigator's clinical judgment orbased on the Columbia Suicide Severity Rating Scale (C-SSRS) [corresponding to aresponse of "Yes" on Item 4 (active suicidal ideation with some intent to act,without specific plan) or Item 5 (active suicidal ideation with specific plan andintent) in the suicidal ideation module of the C-SSRS] or suicidal behavior per theinvestigator's clinical judgment or based on the C-SSRS (corresponding to any scorehigher than 0 in the suicidal behavior module of the C-SSRS)
Participant has positive test result(s) for drugs of abuse (including barbiturates,methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) predoseon the day of the first intranasal treatment session
Participant has any anatomical or medical condition that, per the investigator'sclinical judgment based on assessment, may impede delivery or absorption ofintranasal study drug
Participant has taken any prohibited therapies that would not permit administrationof the first intranasal treatment session
Study Design
Study Description
Connect with a study center
Banfield,
ArgentinaSite Not Available
Instituto Seres
Buenos Aires, 1111
ArgentinaSite Not Available
Ciudad Autonoma de Buenos Aires,
ArgentinaSite Not Available
Ciudad Autónoma De Buenos Aires,
ArgentinaSite Not Available
Cordoba,
ArgentinaSite Not Available
La Plata,
ArgentinaSite Not Available
Mendoza,
ArgentinaSite Not Available
Rosario,
ArgentinaSite Not Available
Caulfield,
AustraliaSite Not Available
Elizabeth Vale,
AustraliaSite Not Available
Frankston,
AustraliaSite Not Available
Monash Alfred Psychiatry Research Centre
Melbourne, 3004
AustraliaSite Not Available
Medical University Innsbruck
Innsbruck, 6020
AustriaSite Not Available
Vienna,
AustriaSite Not Available
Aalst,
BelgiumSite Not Available
Brugge,
BelgiumSite Not Available
Brussel,
BelgiumSite Not Available
Psy Pluriel-Pastur
Bruxelles, 1180
BelgiumSite Not Available
AZ Maria Middelares
Gent, 9000
BelgiumSite Not Available
Jessa Ziekenhuis
Hasselt, 3500
BelgiumSite Not Available
Heusden-Zolder,
BelgiumSite Not Available
Liège,
BelgiumSite Not Available
Pôle Santé Spa
Spa, 4900
BelgiumSite Not Available
Yvoir,
BelgiumSite Not Available
Hospital Universitario Professor Edgar Santos
Bahia, 40110-060
BrazilSite Not Available
Belo Horizonte,
BrazilSite Not Available
Curitiba,
BrazilSite Not Available
Fortaleza,
BrazilSite Not Available
Instituto Goiano de Neuropsiquiatria
Goiania, 74093-040
BrazilSite Not Available
Instituto Bairral de Psiquiatria
Itapira, 13970-905
BrazilSite Not Available
Passo Fundo,
BrazilSite Not Available
Porto Alegre,
BrazilSite Not Available
Recife,
BrazilSite Not Available
Rio de Janeiro,
BrazilSite Not Available
CEMEC - Centro Multidisciplinar de Estudos Clínicos
Santo Andre, 09190-510
BrazilSite Not Available
Hospital Estadual Mario covas
Santo André, 09190-615
BrazilSite Not Available
Sao Bernardo do Campo,
BrazilSite Not Available
Sao Paulo,
BrazilSite Not Available
empty
São Bernardo do Campo,
BrazilSite Not Available
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
São José Do Rio Preto, 15015-500
BrazilSite Not Available
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05409-001
BrazilSite Not Available
São Paulo,
BrazilSite Not Available
Instituto De Neurociencias Dr. Quevedo Hospital Sao Sebastiao
Turvo, 88930-000
BrazilSite Not Available
Bourgas,
BulgariaSite Not Available
Kardzhali,
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment dr. Hristo Stambolski EOOD
Kazanlak, 6100
BulgariaSite Not Available
Pazardzhik,
BulgariaSite Not Available
Pleven,
BulgariaSite Not Available
Plovdiv,
BulgariaSite Not Available
Rousse,
BulgariaSite Not Available
Sofia,
BulgariaSite Not Available
Varna,
BulgariaSite Not Available
Vancouver, British Columbia
CanadaSite Not Available
Kingston, Ontario
CanadaSite Not Available
Ottawa, Ontario
CanadaSite Not Available
Toronto, Ontario
CanadaSite Not Available
Douglas Mental Health Institute
Montreal, Quebec H4H 1R3
CanadaSite Not Available
University of Calgary
Calgary, T2N4Z6
CanadaSite Not Available
Brno,
CzechiaSite Not Available
Clinline s.r.o.
Hostivice, 25301
CzechiaSite Not Available
Narodni ustav dusevniho zdravi
Klecany, 25067
CzechiaSite Not Available
Supervize s.r.o.
Kutna Hora, 28401
CzechiaSite Not Available
Bialbi, spol. s r.o.
Litomerice, 41201
CzechiaSite Not Available
Plzen,
CzechiaSite Not Available
Prague,
CzechiaSite Not Available
Psychiatricka ordinace
Praha 1, 11000
CzechiaSite Not Available
Praha 10,
CzechiaSite Not Available
Praha 2,
CzechiaSite Not Available
Praha 6,
CzechiaSite Not Available
Psychiatricka ambulance Strakonice Ambulantni zarizeni PL Lnare
Strakonice 1, 38629
CzechiaSite Not Available
Parnu Hospital
Parnu, 800100
EstoniaSite Not Available
Tallinn,
EstoniaSite Not Available
Tartu,
EstoniaSite Not Available
Kuopio,
FinlandSite Not Available
Clermont-Ferrand Cedex 1,
FranceSite Not Available
Douai,
FranceSite Not Available
Hôpital Corentin-Celton
Issy-Les-Moulineaux, 92130
FranceSite Not Available
CHU Grenoble
La Tronche, 38700
FranceSite Not Available
CHRU Lille - Hôpital Fontan 1
Lille, 59000
FranceSite Not Available
CHRU Montpellier - Hôpital Lapeyronie
Montpellier Cedex 5, 34295
FranceSite Not Available
Nantes,
FranceSite Not Available
CHU Pasteur - Clinique de Psychiatrie et de Psychologie Médicale
Nice Cedex 1, 06001
FranceSite Not Available
Nîmes,
FranceSite Not Available
Paris,
FranceSite Not Available
Poitiers Cedex,
FranceSite Not Available
CHRU de Tours Clinique Psychiatrique Universitaire
Saint-Cyr-Sur-Loire, 37540
FranceSite Not Available
Toulon Cedex,
FranceSite Not Available
CHU Toulouse - Hôpital de Casselardit
Toulouse, 31059
FranceSite Not Available
Berlin,
GermanySite Not Available
Bochum,
GermanySite Not Available
Gemeinschaftspraxis für Neurologie, Psychiatrie, Psychotherapie
Cham, 93413
GermanySite Not Available
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, 01307
GermanySite Not Available
Gemeinschaftspraxis Sallach/Leonhardt
Gelsenkirchen, 45879
GermanySite Not Available
University Hospital Halle/Saale
Halle, 06112
GermanySite Not Available
Mainz,
GermanySite Not Available
empty
Mannheim,
GermanySite Not Available
Mittweida,
GermanySite Not Available
Oranienburg,
GermanySite Not Available
Pfaffenhofen,
GermanySite Not Available
Neurozentrum Prien
Prien, 83209
GermanySite Not Available
Dr. Kenessey Albert Korhaz-Rendelointezet
Balassagyarmat, 2660
HungarySite Not Available
Budapest,
HungarySite Not Available
Debrecen,
HungarySite Not Available
Gyor,
HungarySite Not Available
Petz Aladar Megyei Oktato Korhaz
Győr, H-9024
HungarySite Not Available
Pecs,
HungarySite Not Available
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7623
HungarySite Not Available
Sopron,
HungarySite Not Available
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
Szeged, 6725
HungarySite Not Available
Szekszárd,
HungarySite Not Available
Vác,
HungarySite Not Available
U.O.P.I. di Psichiatria
Catania, 95100
ItalySite Not Available
Azienda Ospedaliero Universitaria Careggi
Firenze, 50134
ItalySite Not Available
IRCCS Aor San Martino IST
Genova, 16132
ItalySite Not Available
Ospedale San Raffaele
Milano, 20127
ItalySite Not Available
U.O.C. Di Psichiatria
Napoli, 80131
ItalySite Not Available
S.C.D.U. Psichiatria
Orbassano, 10043
ItalySite Not Available
Azienda Ospedaliera di Padova
Padova, 35128
ItalySite Not Available
U.O.C. Di Psichiatria
Roma, 00193
ItalySite Not Available
UOSM Sant'Arsenio
Sant'Arsenio, 84037
ItalySite Not Available
A.O. Universitaria Senese- Ospedale Santa Maria alle Scotte
Siena, 53100
ItalySite Not Available
Korea University Ansan Hospital
Ansan-Si, 425-707
Korea, Republic ofSite Not Available
Gwangju,
Korea, Republic ofSite Not Available
Seoul,
Korea, Republic ofSite Not Available
Kaunas,
LithuaniaSite Not Available
Hospital Bahagia Ulu Kinta
Ipoh, 31250
MalaysiaSite Not Available
Hospital Permai
Johor Bahru, 81200
MalaysiaSite Not Available
Kuala Lumpur,
MalaysiaSite Not Available
Centro de Investigación Clínica del Pacífico
Acapulco, 39670
MexicoSite Not Available
Instituto de Investigación en Pro de la Salud Mental
Durango, 34000
MexicoSite Not Available
Guadalajara,
MexicoSite Not Available
Leon,
MexicoSite Not Available
B&B Investigaciones Médicas
Mazatlan, 82126
MexicoSite Not Available
Mexico,
MexicoSite Not Available
Mexico City,
MexicoSite Not Available
Monterrey,
MexicoSite Not Available
San Luis Potosi,
MexicoSite Not Available
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí, 78200
MexicoSite Not Available
Belchatow,
PolandSite Not Available
Bialystok,
PolandSite Not Available
Bydgoszcz,
PolandSite Not Available
Gdansk,
PolandSite Not Available
Szpital Specjalistyczny im. dr J. Babinskiego SP ZOZ
Krakow, 30-393
PolandSite Not Available
Leszno,
PolandSite Not Available
SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych
Lodz, 92-216
PolandSite Not Available
Lublin,
PolandSite Not Available
empty
Myslowice,
PolandSite Not Available
Klinika Psychiatryczna WUM Mazowieckie Specjalistyczne Centrum Zdrowia im prof Jana Mazurkiewicza
Pruszkow, 05-802
PolandSite Not Available
NZOZ Podkarpackie Centrum Zdrowia Psychicznego
Przemysl, 37-700
PolandSite Not Available
Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard
Torun, 87-100
PolandSite Not Available
NZOZ Prywatna Klinika Psychiatryczna INVENTIVA
Tuszyn, 95-080
PolandSite Not Available
Warszawa,
PolandSite Not Available
Spitalul de Psihiatrie Titan Dr. Constantin Gorgos
Bucuresti, 30442
RomaniaSite Not Available
Bratislava,
SlovakiaSite Not Available
Liptovsky Mikulas,
SlovakiaSite Not Available
Rimavska Sobota,
SlovakiaSite Not Available
Roznava,
SlovakiaSite Not Available
Svidnik,
SlovakiaSite Not Available
Cape Town,
South AfricaSite Not Available
Pretoria,
South AfricaSite Not Available
Welgemoed,
South AfricaSite Not Available
Alcorcón,
SpainSite Not Available
Hosp. Univ. Infanta Cristina
Badajoz, 06080
SpainSite Not Available
Barcelona,
SpainSite Not Available
Bilbao,
SpainSite Not Available
Hosp. Reina Sofia
Córdoba, 14004
SpainSite Not Available
Madrid,
SpainSite Not Available
Hosp. Puerta Del Sur
Mostoles, 28938
SpainSite Not Available
Hosp. Univ. Virgen de La Arrixaca
Murcia, 30120
SpainSite Not Available
Hosp. Regional Univ. de Malaga
Málaga, 29010
SpainSite Not Available
Complexo Hosp. Univ. de Ourense
Ourense, 32005
SpainSite Not Available
Oviedo,
SpainSite Not Available
Palma,
SpainSite Not Available
Pamplona,
SpainSite Not Available
Hosp. El Bierzo
Ponferrada, 24404
SpainSite Not Available
Sabadell,
SpainSite Not Available
Salamanca,
SpainSite Not Available
Sant Boi de Llobregat,
SpainSite Not Available
Centro Asist. Dr. Emili Mira I Lopez
Santa Coloma De Gramanet, 8921
SpainSite Not Available
Torrevieja,
SpainSite Not Available
Hosp. Clinico Univ. de Valencia
Valencia, 46010
SpainSite Not Available
Vitoria-Gasteiz,
SpainSite Not Available
Zamora,
SpainSite Not Available
Su Psykiatri Affektiva
Goteborg, SE-42490
SwedenSite Not Available
Halmstad,
SwedenSite Not Available
Lund,
SwedenSite Not Available
Skövde,
SwedenSite Not Available
ProbarE i Stockholm AB
Solna, SE-17145
SwedenSite Not Available
Stockholm,
SwedenSite Not Available
Kaohsiung,
TaiwanSite Not Available
New Taipei,
TaiwanSite Not Available
Taichung,
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
Taipei,
TaiwanSite Not Available
Taoyuan,
TaiwanSite Not Available
Adana,
TurkeySite Not Available
Ankara,
TurkeySite Not Available
Bursa,
TurkeySite Not Available
Pamukkale University Medical Faculty
Denizli, 20070
TurkeySite Not Available
Gaziantep University Sahinbey Research and Training Hospital
Gaziantep, 27310
TurkeySite Not Available
Istanbul,
TurkeySite Not Available
Kocaeli University Medical Faculty
Kocaeli, 41380
TurkeySite Not Available
Kucukcekmece/Istanbul,
TurkeySite Not Available
Manisa Mental Health Hospital
Manisa, 42250
TurkeySite Not Available
Oanakkale,
TurkeySite Not Available
Sakarya University Medical Faculty Psychiatry Department
Sakarya, 54187
TurkeySite Not Available
Samsun,
TurkeySite Not Available
Onsekiz Mart University Medical Faculty Psychiatry Department
Çanakkale, 17020
TurkeySite Not Available
Ege Universitesi Tip Fakultesi
İzmir, 34371
TurkeySite Not Available
Callington Road Hospital
Bristol, BS4 5BJ
United KingdomSite Not Available
Abraham Cowley Unit
Chertsey, KT16 0AE
United KingdomSite Not Available
Chesterfield,
United KingdomSite Not Available
Derby,
United KingdomSite Not Available
NHS Greater Glasgow and Clyde
Glasgow, G53 7TU
United KingdomSite Not Available
London,
United KingdomSite Not Available
Roseberry Park Hospital
Middlesbrough, TS4 3AF
United KingdomSite Not Available
Northampton,
United KingdomSite Not Available
Oxford,
United KingdomSite Not Available
Royal Preston Hospital
Preston, PR2 9HT
United KingdomSite Not Available
Birmingham, Alabama
United StatesSite Not Available
Little Rock, Arkansas
United StatesSite Not Available
Advanced Research Center Inc
Anaheim, California 92805
United StatesSite Not Available
Clinicas de Salud del Pueblo, Inc
Brawley, California
United StatesSite Not Available
Clinical Training and Research Institute
Burlingame, California 94010
United StatesSite Not Available
CMB Clinical Trials
Colton, California
United StatesSite Not Available
Garden Grove, California
United StatesSite Not Available
Glendale, California
United StatesSite Not Available
Oakland, California
United StatesSite Not Available
Orange, California
United StatesSite Not Available
San Diego, California
United StatesSite Not Available
Artemis Institute for Clinical Research
San Marcos, California 92078
United StatesSite Not Available
San Rafael, California
United StatesSite Not Available
University of Connecticut Health Center
Farmington, Connecticut 06030-6415
United StatesSite Not Available
Hartford, Connecticut
United StatesSite Not Available
New Haven, Connecticut
United StatesSite Not Available
Meridien Research
Bradenton, Florida 34201
United StatesSite Not Available
Gainesville, Florida
United StatesSite Not Available
Florida Clinical Research Center, LLC
Maitland, Florida 32751
United StatesSite Not Available
Miami, Florida
United StatesSite Not Available
Orlando, Florida
United StatesSite Not Available
USF, Department of Psychiatry and Behavioral Neurosciences
Tampa, Florida 33613
United StatesSite Not Available
Atlanta, Georgia
United StatesSite Not Available
Northwest Behavioral Research Center
Marietta, Georgia 30060
United StatesSite Not Available
Northwest Behavioral Research Center
Roswell, Georgia 30076
United StatesSite Not Available
Chicago, Illinois
United StatesSite Not Available
Hoffman Estates, Illinois
United StatesSite Not Available
Joliet, Illinois
United StatesSite Not Available
Maywood, Illinois
United StatesSite Not Available
Mental Health Chicago
Schaumburg, Illinois 60194
United StatesSite Not Available
Skokie, Illinois
United StatesSite Not Available
Iowa City, Iowa
United StatesSite Not Available
Phoenix Medical Research, Inc.
Prairie Village, Kansas 66206
United StatesSite Not Available
Wichita, Kansas
United StatesSite Not Available
Lake Charles, Louisiana
United StatesSite Not Available
Shreveport, Louisiana
United StatesSite Not Available
Baltimore, Maryland
United StatesSite Not Available
Gaithersburg, Maryland
United StatesSite Not Available
CBH Health
Rockville, Maryland 20850
United StatesSite Not Available
Boston, Massachusetts
United StatesSite Not Available
New Bedford, Massachusetts
United StatesSite Not Available
Beacon Clinical Research
Quincy, Massachusetts 02169
United StatesSite Not Available
Watertown, Massachusetts
United StatesSite Not Available
Worcester, Massachusetts
United StatesSite Not Available
Rochester Hills, Michigan
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Michigan 63110
United StatesSite Not Available
University Of Minnesota
Minneapolis, Minnesota 55454
United StatesSite Not Available
Psychiatric Care and Research Center (PCRC)
O Fallon, Missouri 63368
United StatesSite Not Available
O'Fallon, Missouri
United StatesSite Not Available
Saint Charles, Missouri
United StatesSite Not Available
Omaha, Nebraska
United StatesSite Not Available
Cedarhurst, New York
United StatesSite Not Available
New York, New York
United StatesSite Not Available
Staten Island, New York
United StatesSite Not Available
Stony Brook University Medical Center
Stony Brook, New York 11794
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Carolinas Medical Center
Charlotte, North Carolina 28211
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Hickory, North Carolina
United StatesSite Not Available
Cincinnati, Ohio
United StatesSite Not Available
Oklahoma City, Oklahoma
United StatesSite Not Available
Allentown, Pennsylvania
United StatesSite Not Available
Media, Pennsylvania
United StatesSite Not Available
Philadelphia, Pennsylvania
United StatesSite Not Available
Scranton Counseling Center
Scranton, Pennsylvania 18503
United StatesSite Not Available
Lincoln, Rhode Island
United StatesSite Not Available
Providence, Rhode Island
United StatesSite Not Available
Charleston, South Carolina
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
KRK Medical Research
Arlington, Texas 76012
United StatesSite Not Available
Austin, Texas
United StatesSite Not Available
Dallas, Texas
United StatesSite Not Available
Houston, Texas
United StatesSite Not Available
Wichita Falls, Texas
United StatesSite Not Available
Neuropsychiatric Associates, LLC - The Woodstock Research Center
Woodstock, Vermont 5091
United StatesSite Not Available
Charlottesville, Virginia
United StatesSite Not Available
Carilion Clinic-Virginia Tech Carilion School of Medicine
Roanoke, Virginia 24014
United StatesSite Not Available
Pacific Institute of Medical Sciences
Bethel, Washington 98011
United StatesSite Not Available
Pacific Institute of Medical Sciences
Bothel, Washington 98011
United StatesSite Not Available
Pacific Institute of Medical Sciences
Bothell, Washington 98011
United StatesSite Not Available
Dean Foundation for Health, Research and Education, Inc.
Middleton, Wisconsin 53562
United StatesSite Not Available
Waukesha, Wisconsin
United StatesSite Not Available

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