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Clinical trials for 2016-004422-42

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44064   clinical trials with a EudraCT protocol, of which   7320   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).

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    1 result(s) found for: 2016-004422-42. Displaying page 1 of 1.
    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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.

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