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CompletedNCT04338321

Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release for depression

This study is completed in Belgium, in Argentina, in Austria, .... It is testing Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release for depression.

DepressionDrugFrom 18 Years to 74 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

Then choose your country and confirm availability with each study site.

In plain English

Key information made simple

What is this study testing?

This study is testing whether Esketamine 28 mg may be useful for adults experiencing depression.

What would participation involve?

Participants may receive Esketamine 28 mg, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Argentina, in Austria, and in Belgium.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: August 21, 2020
Recruitment status
Completed
Enrollment listed in the registry
676
Sponsor
Janssen-Cilag International NV
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
Belgium, Argentina, Austria, ...
Age range
From 18 Years to 74 Years
Official registry ID
NCT04338321
Official title
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Argentina · 8 sites
  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
    Buenos Aires
    Site status: Not listed — confirm with the team
  • FunDaMos
    Buenos Aires
    Site status: Not listed — confirm with the team
  • CEN Consultorios Especializados en Neurociencias
    Córdoba
    Site status: Not listed — confirm with the team
  • Fundacion Lennox
    Córdoba
    Site status: Not listed — confirm with the team
  • Instituto Medico DAMIC
    Córdoba
    Site status: Not listed — confirm with the team
  • Sanatorio Prof Leon S Morra S A
    Córdoba
    Site status: Not listed — confirm with the team
  • Instituto de Neurociencias San Agustin
    La Plata
    Site status: Not listed — confirm with the team
  • C I A P Centro de investigacion y Asistencia en Psiquiatria
    Rosario
    Site status: Not listed — confirm with the team
Austria · 3 sites
  • Medical University Graz
    Graz
    Site status: Not listed — confirm with the team
  • Schmitz and Schmitz
    Vienna
    Site status: Not listed — confirm with the team
  • Medical University Vienna MUV
    Vienna
    Site status: Not listed — confirm with the team
Belgium · 6 sites
  • Anima
    Alken
    Site status: Not listed — confirm with the team
  • Pz Duffel
    Duffel
    Site status: Not listed — confirm with the team
  • Clinique Psychiatrique des Frères Alexiens
    Henri-Chapelle
    Site status: Not listed — confirm with the team
  • Sint-Franciskusziekenhuis
    Heusden-Zolder
    Site status: Not listed — confirm with the team
  • ARIADNE
    Lede
    Site status: Not listed — confirm with the team
  • CHU de Liege
    Liège
    Site status: Not listed — confirm with the team
Brazil · 5 sites
  • CPN - Centro de Pesquisa em Neurociências Ltda
    Belo Horizonte
    Site status: Not listed — confirm with the team
  • Trial Tech Tecnologia em Pesquisas com Medicamentos
    Curitiba
    Site status: Not listed — confirm with the team
  • Ruschel Medicina e Pesquisa Clínica Ltda
    Rio de Janeiro
    Site status: Not listed — confirm with the team
  • C J S Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana)
    São Paulo
    Site status: Not listed — confirm with the team
  • BR Trials
    São Paulo
    Site status: Not listed — confirm with the team
Bulgaria · 8 sites
  • State Psychiatric Hospital Kardzhali
    Kardzhali
    Site status: Not listed — confirm with the team
  • UMHAT 'Dr. Georgi Stranski', EAD
    Pleven
    Site status: Not listed — confirm with the team
  • Mental Health Center - Plovdiv
    Plovdiv
    Site status: Not listed — confirm with the team
  • Mental Health Center - Rousse
    Rousse
    Site status: Not listed — confirm with the team
  • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
    Sofia
    Site status: Not listed — confirm with the team
  • MHC - Sofia, EOOD
    Sofia
    Site status: Not listed — confirm with the team
  • Centre for Mental Health Prof.N.Shipkovenski EOOD
    Sofia
    Site status: Not listed — confirm with the team
  • University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD
    Sofia
    Site status: Not listed — confirm with the team
Czechia · 8 sites
  • Psychiatricka ambulance Saint Anne s.r.o.
    Brno
    Site status: Not listed — confirm with the team
  • Psychiatricka ambulance, MUDr. Marta Holanova
    Brno
    Site status: Not listed — confirm with the team
  • NeuropsychiatrieHK, s.r.o.
    Hradec Kralove-Vekose
    Site status: Not listed — confirm with the team
  • A Shine S R O
    Pilsen
    Site status: Not listed — confirm with the team
  • Clintrial s r o
    Prague
    Site status: Not listed — confirm with the team
  • AD71 s.r.o.
    Prague
    Site status: Not listed — confirm with the team
  • Medical Services Prague S R O
    Prague
    Site status: Not listed — confirm with the team
  • Institut Neuropsychiatricke pece
    Prague
    Site status: Not listed — confirm with the team
Denmark · 2 sites
  • Aalborg University Hospital
    Aalborg
    Site status: Not listed — confirm with the team
  • Psykiatrien i Region Syddanmark
    Esbjerg N
    Site status: Not listed — confirm with the team
Finland · 3 sites
  • Mederon LTD at ARTES
    Helsinki
    Site status: Not listed — confirm with the team
  • Psykiatrinen Palvelukeskus Solvum Oy
    Helsinki
    Site status: Not listed — confirm with the team
  • Savon Psykiatripalvelu
    Kuopio
    Site status: Not listed — confirm with the team
Germany · 38 sites
  • Universitaetsklinikum der RWTH Aachen
    Aachen
    Site status: Not listed — confirm with the team
  • Rheinhessen Fachklinik Alzey
    Alzey
    Site status: Not listed — confirm with the team
  • Emovis GmbH
    Berlin
    Site status: Not listed — confirm with the team
  • Charite Campus Benjamin Franklin
    Berlin
    Site status: Not listed — confirm with the team
  • Medizinisches Versorgungszentrum LiO GmbH
    Berlin
    Site status: Not listed — confirm with the team
  • Alexander Schulze - Germany
    Berlin
    Site status: Not listed — confirm with the team
  • Praxis Dr. med. Kirsten Hahn
    Berlin
    Site status: Not listed — confirm with the team
  • Vivantes Klinikum Spandau
    Berlin
    Site status: Not listed — confirm with the team
  • Universitatsklinikum Bonn
    Bonn
    Site status: Not listed — confirm with the team
  • Klinikum Chemnitz gGmbH
    Chemnitz
    Site status: Not listed — confirm with the team
  • Carl-Thiem-Klinikum Cottbus gGmbH
    Cottbus
    Site status: Not listed — confirm with the team
  • Klinikum Dortmund gGmbH
    Dortmund
    Site status: Not listed — confirm with the team
  • Universitatsklinikum Carl Gustav Carcus Dresden
    Dresden
    Site status: Not listed — confirm with the team
  • Universitatsklinikum Frankfurt
    Frankfurt am Main
    Site status: Not listed — confirm with the team
  • Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik
    Freiburg im Breisgau
    Site status: Not listed — confirm with the team
  • SRH Waldklinikum Gera GmbH
    Gera
    Site status: Not listed — confirm with the team
  • Georg August Universitat Universitatsmedizin Gottingen
    Göttingen
    Site status: Not listed — confirm with the team
  • Evangelisches Krankenhaus Bethanien gGmbH
    Greifswald
    Site status: Not listed — confirm with the team
  • Universitaetsklinik Hamburg-Eppendorf
    Hamburg
    Site status: Not listed — confirm with the team
  • Klinische Forschung Hamburg
    Hamburg
    Site status: Not listed — confirm with the team
  • Klinische Forschung Hannover-Mitte GmbH
    Hanover
    Site status: Not listed — confirm with the team
  • Medizinische Hochschule Hannover
    Hanover
    Site status: Not listed — confirm with the team
  • Universität Heidelberg
    Heidelberg
    Site status: Not listed — confirm with the team
  • Oberhavel Kliniken GmbH
    Hennigsdorf
    Site status: Not listed — confirm with the team
  • Universitätsklinikum des Saarlandes
    Homburg
    Site status: Not listed — confirm with the team
  • Universitatsklinikum Jena
    Jena
    Site status: Not listed — confirm with the team
  • Panakeia - Arzneimittelforschung GmbH
    Leipzig
    Site status: Not listed — confirm with the team
  • Universitaetsklinikum Magdeburg A.oe.R
    Magdeburg
    Site status: Not listed — confirm with the team
  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
    Mainz
    Site status: Not listed — confirm with the team
  • Pharmakologisches Studienzentrum Chemnitz GmbH
    Mittweida
    Site status: Not listed — confirm with the team
  • Universitatsklinikum Munster
    Münster
    Site status: Not listed — confirm with the team
  • Ruppiner Kliniken
    Neuruppin
    Site status: Not listed — confirm with the team
  • Praxis Prof. Steinwachs
    Nuremberg
    Site status: Not listed — confirm with the team
  • Johanniter Krankenhaus Oberhausen
    Oberhausen
    Site status: Not listed — confirm with the team
  • Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik
    Pfaffenhofen
    Site status: Not listed — confirm with the team
  • Somni Bene GmbH
    Schwerin
    Site status: Not listed — confirm with the team
  • Klinische Forschung Schwerin GmbH
    Schwerin
    Site status: Not listed — confirm with the team
  • Klinikum der Hansestadt Stralsund GmbH-Ambulanz-Klinik für Psychiatrie und Psychotherapie - Germany
    Stralsund
    Site status: Not listed — confirm with the team
Greece · 9 sites
  • Aiginition Hospital of Athens
    Athens
    Site status: Not listed — confirm with the team
  • 'Dafni' Psychiatric Hospital of Attica
    Athens
    Site status: Not listed — confirm with the team
  • Venizeleio General Hospital
    Crete
    Site status: Not listed — confirm with the team
  • Psychiatric Clinic 'Agios Charalampos'
    Heraklion
    Site status: Not listed — confirm with the team
  • University General Hospital of Ioannina
    Ioannina
    Site status: Not listed — confirm with the team
  • University General Hospital of Rio Patras
    Pátrai
    Site status: Not listed — confirm with the team
  • 424 Military Hospital of Thessaloniki
    Thessaloniki
    Site status: Not listed — confirm with the team
  • Psychiatric Hospital of Thessaloniki
    Thessaloniki
    Site status: Not listed — confirm with the team
  • G Papanikolaou Hospital of Thessaloniki
    Thessaloniki
    Site status: Not listed — confirm with the team
Hungary · 9 sites
  • Semmelweis Egyetem
    Budapest
    Site status: Not listed — confirm with the team
  • Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
    Budapest
    Site status: Not listed — confirm with the team
  • Processus Kft
    Budapest
    Site status: Not listed — confirm with the team
  • Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
    Debrecen
    Site status: Not listed — confirm with the team
  • Bugat Pal Korhaz
    Gyöngyös
    Site status: Not listed — confirm with the team
  • Petz Aladar Megyei Oktato Korhaz
    Győr
    Site status: Not listed — confirm with the team
  • Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
    Kalocsa
    Site status: Not listed — confirm with the team
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
    Nyíregyháza
    Site status: Not listed — confirm with the team
  • Pecsi Tudomanyegyetem Klinikai Kozpont
    Pécs
    Site status: Not listed — confirm with the team
Israel · 6 sites
  • Rambam Medical Center
    Haifa
    Site status: Not listed — confirm with the team
  • Shalvata Mental Health Center
    Hod HaSharon
    Site status: Not listed — confirm with the team
  • Beer Yaakov Mental Health Center
    Lod
    Site status: Not listed — confirm with the team
  • Geha Mental Health Center
    Petah Tikva
    Site status: Not listed — confirm with the team
  • Sheba Medical Center
    Ramat Gan
    Site status: Not listed — confirm with the team
  • Tel Aviv Sourasky Medical Center
    Telaviv
    Site status: Not listed — confirm with the team
Kazakhstan · 3 sites
  • Republican Scientific and Practical Center of Mental Health
    Almaty
    Site status: Not listed — confirm with the team
  • Medical Center for Psychological Healt SME
    Nur-Sultan
    Site status: Not listed — confirm with the team
  • East-Kazakhstan Regional Centre of Mental Health
    Ust-Kamenogorsk
    Site status: Not listed — confirm with the team
Malaysia · 5 sites
  • Hospital Raja Permaisuri Bainun
    Ipoh
    Site status: Not listed — confirm with the team
  • Hospital Kuala Lumpur
    Kuala Lumpur
    Site status: Not listed — confirm with the team
  • University Malaya Medical Centre
    Kuala Lumpur
    Site status: Not listed — confirm with the team
  • Hospital Pengajar Universiti Putra Malaysia
    Serdang
    Site status: Not listed — confirm with the team
  • Hospital Tuanku Jaafar
    Seremban
    Site status: Not listed — confirm with the team
Netherlands · 3 sites
  • Brain Research Center
    Amsterdam
    Site status: Not listed — confirm with the team
  • AMC
    Amsterdam
    Site status: Not listed — confirm with the team
  • LUMC
    Leiden
    Site status: Not listed — confirm with the team
Norway · 3 sites
  • Haukeland University Hospital
    Hordaland
    Site status: Not listed — confirm with the team
  • Sykehuset Ostfold
    Moss
    Site status: Not listed — confirm with the team
  • St Olav University Hospital
    Trondheim
    Site status: Not listed — confirm with the team
Poland · 10 sites
  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
    Bialystok
    Site status: Not listed — confirm with the team
  • Osrodek Badan Klinicznych CLINSANTE S C
    Bydgoszcz
    Site status: Not listed — confirm with the team
  • Uniwersyteckie Centrum Kliniczne
    Gdansk
    Site status: Not listed — confirm with the team
  • Centrum Badan Klinicznych PI House sp z o o
    Gdansk
    Site status: Not listed — confirm with the team
  • Centrum Medyczne Care Clinic Katowice
    Katowice
    Site status: Not listed — confirm with the team
  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
    Leszno
    Site status: Not listed — confirm with the team
  • Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego
    Lodz
    Site status: Not listed — confirm with the team
  • SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych
    Lodz
    Site status: Not listed — confirm with the team
  • Centrum Medyczne Luxmed Sp z o o
    Lublin
    Site status: Not listed — confirm with the team
  • Osrodek Badan Klinicznych CLINSANTE S C
    Torun
    Site status: Not listed — confirm with the team
Portugal · 6 sites
  • Hospital de Braga
    Braga
    Site status: Not listed — confirm with the team
  • Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa
    Guilhufe - Penafiel
    Site status: Not listed — confirm with the team
  • Hosp. Cuf Tejo
    Lisbon
    Site status: Not listed — confirm with the team
  • Fund. Champalimaud
    Lisbon
    Site status: Not listed — confirm with the team
  • Centro Hospitalar de Lisboa Norte Hospital Santa Maria
    Lisbon
    Site status: Not listed — confirm with the team
  • Uls Loures Odivelas - Hosp. Loures
    Loures
    Site status: Not listed — confirm with the team
South Africa · 3 sites
  • Cape Town Clinical Research Centre
    Cape Town
    Site status: Not listed — confirm with the team
  • Flexivest 14 Research
    Cape Town
    Site status: Not listed — confirm with the team
  • Gert Bosch Pretoria South Africa
    Garsfontein
    Site status: Not listed — confirm with the team
South Korea · 6 sites
  • Chonnam National University Hospital
    Gwangju
    Site status: Not listed — confirm with the team
  • Wonkwang University Hospital
    Iksan
    Site status: Not listed — confirm with the team
  • KyungHee University Hospital
    Seoul
    Site status: Not listed — confirm with the team
  • Korea University Anam Hospital
    Seoul
    Site status: Not listed — confirm with the team
  • Severance Hospital Yonsei University Health System
    Seoul
    Site status: Not listed — confirm with the team
  • Samsung Medical Center
    Seoul
    Site status: Not listed — confirm with the team
Sweden · 6 sites
  • Psykiatriska kliniken
    Gothenburg
    Site status: Not listed — confirm with the team
  • Affecta Pskyiatrimottagning
    Halmstad
    Site status: Not listed — confirm with the team
  • Psykiatriska kliniken
    Luleå
    Site status: Not listed — confirm with the team
  • ProbarE i Lund AB
    Lund
    Site status: Not listed — confirm with the team
  • ONE LIFETIME Lakarmottagning
    Skövde
    Site status: Not listed — confirm with the team
  • ProbarE i Stockholm AB
    Stockholm
    Site status: Not listed — confirm with the team
Taiwan · 10 sites
  • Changhua Christian Hospital
    Changhua
    Site status: Not listed — confirm with the team
  • Hualien Tzu Chi Hospital
    Hualien City
    Site status: Not listed — confirm with the team
  • Kai-Syuan Psychiatric Hospital
    Kaohsiung City
    Site status: Not listed — confirm with the team
  • Chang Gung Memorial Hospital
    Kaohsiung City
    Site status: Not listed — confirm with the team
  • National Cheng Kung University Hospital
    Tainan
    Site status: Not listed — confirm with the team
  • National Taiwan University Hospital
    Taipei
    Site status: Not listed — confirm with the team
  • Mackay Memorial Hospital
    Taipei
    Site status: Not listed — confirm with the team
  • Taipei Medical University
    Taipei
    Site status: Not listed — confirm with the team
  • Taipei Veterans General Hospital
    Taipei
    Site status: Not listed — confirm with the team
  • Chang Gung Memorial Hospital
    Taoyuan
    Site status: Not listed — confirm with the team
Türkiye · 10 sites
  • Hacettepe University Medical Faculty
    Ankara
    Site status: Not listed — confirm with the team
  • Bursa Yuksek Ihtisas Training and Research Hospital
    Bursa
    Site status: Not listed — confirm with the team
  • Uludag University Medical Faculty
    Bursa
    Site status: Not listed — confirm with the team
  • Bakirkoy Mental Health Training and Research Hospital
    Istanbul
    Site status: Not listed — confirm with the team
  • Erenkoy Mental Health Hospital
    Istanbul
    Site status: Not listed — confirm with the team
  • Uskudar University Neuropsychiatry Hospital
    Istanbul
    Site status: Not listed — confirm with the team
  • Ege Universitesi Tip Fakultesi
    Izmir
    Site status: Not listed — confirm with the team
  • Selcuk University Medical Faculty
    Konya
    Site status: Not listed — confirm with the team
  • Liv Hospital
    Samsun
    Site status: Not listed — confirm with the team
  • Namik Kemal University
    Tekirdağ
    Site status: Not listed — confirm with the team
United Arab Emirates · 1 site
  • American Center for Psychiatry and Neurology
    Abu Dhabi
    Site status: Not listed — confirm with the team

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In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg, Quetiapine XR 50 mg, Quetiapine XR 100 mg, Quetiapine XR 150 mg, SSRI/SNRI. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with depression; age range: From 18 Years to 74 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Janssen-Cilag International NV, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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