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CompletedN/A

Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI

NCT05530668 · ESKETAM · University Hospital, Strasbourg, France

Closed to entry
Status
Not accepting participants
Not applicable
Phase
13
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

There are already recently published data on the tolerability and efficacy of the combination of ketamine and/or esketamine with MAOIs. However, these reports are few and far between, and to our knowledge, there are no data involving intranasal esketamine. Given the numerous interactions between MAOIs and other antidepressants, and the impossibility of combination, this pharmacological class is neglected. This is despite the fact that MAOIs are the only truly tri-aminergic drugs, that they have unparalleled efficacy in certain forms of resistant apathetic depression, and that new, more dietary permissive forms have appeared on the market. The arrival of antidepressants that can be combined with MAOIs, such as ketamine and esketamine, changes the situation and could offer a new treatment opportunity to many patients in a therapeutic impasse. For these opportunities to become a reality, sharing the clinical experience gained by specialized centers is essential.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number of adverse events for each patient

    Measured over Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion criteria: * Major subject. * Having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022. * Not objecting to the reuse of their data for scientific research purposes. Exclusion Criteria: \- Subject who has expressed opposition to the reuse of their data for scientific research purposes.

Where

1 study site

FacilityCityRegionCountry
Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - FranceStrasbourgFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05530668 on ClinicalTrials.gov →

Last updated in the registry 2023-11-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits