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

Depression Anxiety Disorder Clinical Trial

— ESKETAM  

Official title:

Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective Monoamine Oxidase Inhibitors (MAOIs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530668
• Other study ID #: 8588
• Status: Completed
• Start date: April 11, 2022
• Est. completion date: December 11, 2022

Study information

• Verified date: November 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 11, 2022
• Est. primary completion date: September 11, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression Anxiety Disorder

Locations

Country	Name	City	State
France	Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events for each patient		Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined