Depression Anxiety DisorderESKETAMNCT05530668
Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI
An observational study of Depression Anxiety Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Anxiety Disorder
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2022to 11 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject.having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.
Who may be able to join
- 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.
Who cannot join
- Subject who has expressed opposition to the reuse of their data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: 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.
- Conditions
- Depression Anxiety Disorder
- Keywords
- Depression Disorder, Anxiety Disorder, intranasal esketamine, monoamine oxidase inhibitors (MAOIs), MAOIs, antidepressants, ketamine
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events for each patient
Measured: Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start11 Apr 2022
- Primary completion11 Sep 2022
- Study completion11 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530668
- Sponsor's protocol ID
- 8588
- Acronym
- ESKETAM
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40456292Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
PubMed 39428602
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective Monoamine Oxidase Inhibitors (MAOIs)
- ClinicalTrials.gov ID
- NCT05530668
- Acronym / sponsor ID
- ESKETAM / 8588
- Conditions
- Depression Anxiety Disorder
- Keywords
- Depression Disorder, Anxiety Disorder, intranasal esketamine, monoamine oxidase inhibitors (MAOIs), MAOIs, antidepressants, ketamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject.having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject who has expressed opposition to the reuse of their data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of adverse events for each patient
Time frame: Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 40456292Dormegny-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.
- Derived from this study: PubMed 39428602Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Anxiety Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events for each patient (time frame: Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.