NCT05530668

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

September 2, 2022

Last Update Submit

November 8, 2023

Conditions

Keywords

Depression DisorderAnxiety Disorderintranasal esketaminemonoamine oxidase inhibitors (MAOIs)MAOIsantidepressantsketamine

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events for each patient

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject.having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Subject who has expressed opposition to the reuse of their data for scientific research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

Related Publications (1)

  • Dormegny-Jeanjean LC, Lenoir S, Humbert I, Mainberger OAE, Lozere C, Meyer C, Geny B, Michel B, Foucher JR, de Crespin de Billy C. Cardiovascular Effects of Non-Selective Monoamine Oxidase Inhibitors and Intranasal Esketamine Combination in Depression - A Quasi-Experimental Design with Bayesian Analyses. Pharmacopsychiatry. 2025 Nov;58(6):273-283. doi: 10.1055/a-2590-3469. Epub 2025 Jun 2.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

April 11, 2022

Primary Completion

September 11, 2022

Study Completion

December 11, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations