Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Esketamine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    49 result(s) found for: Esketamine. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2020-004172-17 Sponsor Protocol Number: ETES Start Date*: 2021-04-26
    Sponsor Name:Medizinische Universität Innsbruck
    Full Title: Electroconvulsive therapy vs. esketamine nasal spray in treatment-resistant depression: a longitudinal, randomized efficacy comparison pilot study
    Medical condition: treatment resistant depression
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002669-20 Sponsor Protocol Number: 03KET2018 Start Date*: 2018-09-18
    Sponsor Name:Celon Pharma SA
    Full Title: A multicentre, double-blind, randomised, placebo - controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subjects with treatment-resistant bipolar depre...
    Medical condition: Eketamine, ketamine’s enantiomer, is designed for use in tretment resistant depression, both unipolar and bipolar. Many publications have demonstrated the effect of ketamine/esketamine (mainly admi...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001963-22 Sponsor Protocol Number: 02KET2018 Start Date*: 2018-08-29
    Sponsor Name:Celon Pharma SA
    Full Title: A multicentre, double-blind, randomised, placebo - controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subject with treatment-resistant depression in ...
    Medical condition: Eketamine, ketamine’s enantiomer, is designed for use in tretment resistant depression, both unipolar and bipolar. Many publications have demonstrated the effect of ketamine/esketamine (mainly admi...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022772-31 Sponsor Protocol Number: 20100812v2 Start Date*: 2011-02-09
    Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Psychiatrie und Psychotherapie
    Full Title: Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations using Ketamine and pharmacological Magnetic Resonance Imaging
    Medical condition: Quantify changes of resting-state functional connectivity in response to Esketamine in healthy volunteers.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10029817 Nuclear magnetic resonance imaging brain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000640-21 Sponsor Protocol Number: KetCRPS-2 Start Date*: 2021-11-10
    Sponsor Name:Center for Pain Medicine, Erasmus MC
    Full Title: Long-term pain modulation by intravenous esketamine in Complex Regional Pain Syndrome: a non-inferiority study
    Medical condition: Complex Regional Pain Syndrome
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004291-18 Sponsor Protocol Number: 54135419TRD4010 Start Date*: 2021-04-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: Open-label Long-Term Extension Study for Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing Esketamine Nasal Spray Treatment From Study 54135419TRD3013
    Medical condition: Treatment-Resistant Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10081270 Major depressive disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) CZ (Completed) HU (Completed) PL (Completed) BG (Completed) FI (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004586-24 Sponsor Protocol Number: ESKETINTRD3003 Start Date*: 2015-09-22
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression
    Medical condition: Treatment-resistant Major Depression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) PL (Completed) ES (Completed) HU (Completed) CZ (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003280-38 Sponsor Protocol Number: PSY-NIL-0006 Start Date*: 2016-05-04
    Sponsor Name:Medical University of Vienna
    Full Title: Positron Emission Tomography assessment of Ketamine Binding of the Serotonin Transporter and its Relevance for Rapid Antidepressant Response
    Medical condition: 20 patients with severe unipolar depression (structured clinical interview for DSM-IV and the 17-item Hamilton Depression Rating Scale), also 20 age and sex matched healthy controls. plus 12 HC f...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10045543 Unipolar depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003578-34 Sponsor Protocol Number: 54135419TRD3008 Start Date*: 2016-08-02
    Sponsor Name:Janssen-Cilag International NV
    Full Title: An Open-label Long-term Extension Safety Study of Intranasal Esketamine in Treatment resistant Depression
    Medical condition: Treatment-resistant Major Depression
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) ES (Ongoing) PL (Completed) HU (Completed) CZ (Completed) SK (Completed) LT (Completed) AT (Completed) FI (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004005-11 Sponsor Protocol Number: ESKETINTRD2003 Start Date*: 2013-12-17
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Double-Blind, Doubly-Randomized, Placebo-Controlled Study of Intranasal Esketamine in an Adaptive Treatment Protocol to Assess Safety and Efficacy in Treatment-Resistant Depression (SYNAPSE)
    Medical condition: Treatment Resistant Major Depression
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000473-25 Sponsor Protocol Number: ESKEFIB Start Date*: 2020-06-30
    Sponsor Name:Grand Hôpital de Charleroi
    Full Title: ESKETamine for FIBromyalgia treatment
    Medical condition: Patients diagnosed with a fibromyalgia syndrome as established by the 2016 ACR criteria and presenting criteria of central sensitization syndrome (based of the CSI (CSI>40)).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002667-42 Sponsor Protocol Number: ABR53999 Start Date*: 2015-09-09
    Sponsor Name:AMC
    Full Title: Sedation with propofol TCI during ERCP: Is the combination with esketamine more effective and safer than with alfentanil (SPEKA): A randomized controlled multicentre trial
    Medical condition: Patients undergoing ERCPs under propofol sedation combined with ketamine or alfentanil given by trained anesthesia nurse.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004422-42 Sponsor Protocol Number: ESKETINSUI2002 Start Date*: 2017-10-02
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensiv...
    Medical condition: Major Depressive Disorder with Imminent Risk of Suicide
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10042458 Suicidal ideation PT
    20.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    20.0 10037175 - Psychiatric disorders 10012397 Depression suicidal PT
    20.0 10037175 - Psychiatric disorders 10065604 Suicidal behaviour PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Restarted) BE (Completed) PL (Completed) IT (Completed) BG (Completed) FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005992-17 Sponsor Protocol Number: ESKETIVTRD2001 Start Date*: 2012-05-23
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Double-Blind, Double-Randomization, Placebo-Controlled Study of the Efficacy of Intravenous Esketamine in Adult Subjects with Treatment-Resistant Depression
    Medical condition: Treatment Resistant Major Depression
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004588-19 Sponsor Protocol Number: ESKETINTRD3005 Start Date*: 2015-08-04
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects with Tre...
    Medical condition: Treatment-resistant Major Depression
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) ES (Completed) GB (Completed) LT (Completed) FI (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002992-33 Sponsor Protocol Number: 54135419TRD3013 Start Date*: 2020-08-04
    Sponsor Name:Janssen-Cilag International NV
    Full 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 Wit...
    Medical condition: Treatment-Resistant Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10081270 Major depressive disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) CZ (Completed) PL (Completed) DE (Completed) HU (Completed) FR (Completed) BE (Completed) PT (Completed) BG (Completed) DK (Completed) AT (Completed) NO (Completed) FI (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004585-22 Sponsor Protocol Number: ESKETINTRD3002 Start Date*: 2015-08-10
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult S...
    Medical condition: Treatment-resistant Major Depression
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) ES (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-005116-64 Sponsor Protocol Number: 16092021 Start Date*: 2021-12-13
    Sponsor Name:Aarhus University Hospital, Department of Anesthesiology
    Full Title: Low-dose ketamine as an adjunct to morphine for acute pain in the ED: a randomized, double-blinded, superiority trial
    Medical condition: Acute pain in the Emergency Department
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004867 10066714 Acute pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-004584-20 Sponsor Protocol Number: ESKETINTRD3001 Start Date*: 2015-09-16
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subj...
    Medical condition: Treatment-resistant Major Depression
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) SK (Completed) HU (Completed) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003992-23 Sponsor Protocol Number: 54135419SUI3002 Start Date*: 2017-07-26
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Sympto...
    Medical condition: Major Depressive Disorder with Imminent Risk of Suicide
    Disease: Version SOC Term Classification Code Term Level
    20.1 10037175 - Psychiatric disorders 10042458 Suicidal ideation PT
    20.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    20.0 10037175 - Psychiatric disorders 10012397 Depression suicidal PT
    20.0 10037175 - Psychiatric disorders 10065604 Suicidal behaviour PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) PL (Completed) CZ (Completed) AT (Completed) LT (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 13 17:19:28 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA