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

This observational trial (n=13) was conducted by the University Hospital, Strasbourg, France. The study aimed to assess the tolerance and potential synergistic effect of combining intranasal esketamine with non-selective MAOIs in patients with depression and anxiety disorders.

The study involved a retrospective analysis of files from patients who had been treated with intranasal esketamine between January 1, 2018, and March 31, 2022.

The primary outcome measure was the number of adverse events for each patient during the specified period. The trial enrolled 13 participants who met the inclusion criteria of being major subjects treated with intranasal esketamine within the specified timeframe and not objecting to the reuse of their data for scientific research purposes.

The study, which started on April 11, 2022, and completed on December 11, 2022, was designed as an observational case-only study with a retrospective time perspective. It was conducted at the Service de physiologie – Explorations fonctionnelles – CHU de Strasbourg, France.

Topic Depression Anxiety
Compound Ketamine
Country France
Visit trial
Status Completed
Results Published No
Start date 11 April 2022
End date 11 December 2022
Phase Not Applicable
Design Open
Type Observational
Generation Second
Participants 13
Sex All
Age 18- 99
Therapy No

Trial Details

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.

Trial Number NCT05530668

Data attribution

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