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

September 29, 2022 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Ludovic Dormegny-Jeanjean, MD
        • Sub-Investigator:
          • Jack FOUCHER, MD
        • Sub-Investigator:
          • Olivier MAINBERGER, MD
        • Sub-Investigator:
          • Clément De Crespin de Billy, MD
        • Sub-Investigator:
          • Suzie Lenoir, MD
        • Sub-Investigator:
          • Bruno Michel, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events for each patient
Time Frame: Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined
Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Anticipated)

December 11, 2022

Study Completion (Anticipated)

December 11, 2022

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8588

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression Anxiety Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe