Depression - Major Depressive DisorderSKESINCT06806475
Sustained Ketamine Effectiveness for Suicidal Ideation
An observational study of Depression - Major Depressive Disorder and Suicide, run by University Hospital, Montpellier at 1 site in France.
Trial summary
As part of the usual clinical activity of the Emergency and Post-Emergency Psychiatric Department, IV ketamine is used to treat suicidal crises in depressed patients hospitalized as an add-on to the treatment of depression. This infusion can be repeated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Suicide
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 23 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated with IV ketamine in the Psychiatric Emergency and Post-Emergency Department (University Hospital, Montpellier) in context of suicidal crisis over the period from June 2022 to March 2024
Who may be able to join
- Patients treated with IV ketamine in the Psychiatric Emergency and Post-Emergency Department (University Hospital, Montpellier) in context of suicidal crisis
- over 18 y.o
Who cannot join
- Opposition to data use
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship or curatorship)
- Subject not affiliated to a social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SUSTAINED KETAMINE EFFECTIVENESS for SUICIDAL IDEATION
As part of the usual clinical activity of the Emergency and Post-Emergency Psychiatric Department, IV ketamine is used to treat suicidal crises in depressed patients hospitalized as an add-on to the treatment of depression. This infusion can be repeated.
Patients are systematically reassessed twice in the month following the last infusion, to ensure that the suicidal crisis is progressing. Psychometric assessments are part of routine care, to ensure systematic evaluation of psychopathology, intensity of depression and suicidality.
Therefore existing data were re-used from the medical records of patients who had received ketamine infusions to assess the effect of ketamine on suicidal ideation and behaviour.
- Conditions
- Depression - Major Depressive Disorder, Suicide
- Keywords
- suicide, depression, major depressive disorder, ketamine
- Medical subject headings
- Suicide, Depression, Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
suicidal ideation at 7 days after IV ketamine administration
evolution of suicidal ideation at 7 days after IV ketamine administration in the context of a suicidal crisis using severity of suicidal ideation according to C-SSRS (COLUMBIA-SUICIDE SEVERITY RATING SCALE)
The ideation severity subscale ranges from 1 to 5 (higher score indicating more severe ideation). The ideation intensity subscale includes 5 questions each ranging from 1 to 5 (higher score indication more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Measured: 7 days
Secondary outcomes (8)
suicidal ideation at 1 month after IV ketamine administration
evolution of suicidal ideation at 7 days after IV ketamine administration in the context of a suicidal crisis using severity of suicidal ideation according to C-SSRS (COLUMBIA-SUICIDE SEVERITY RATING SCALE)
The ideation severity subscale ranges from 1 to 5 (higher score indicating more severe ideation). The ideation intensity subscale includes 5 questions each ranging from 1 to 5 (higher score indication more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Measured: 1 month
Severity of depressive symptomatology at 7 days
change in depressive symptomatology at 1 week using Montgomery-Åsberg Depression Rating Scale (MADRS)
The scale consists of 10 items rated from 0 to 6. A score between 0 and 6 indicates euthymia, a score between 7 and 19 mild depression, a score between 20 and 34 moderate depression and a score above 34 severe depression.
Measured: 7 days
Severity of depressive symptomatology at 1 month
change in depressive symptomatology at 1 week using Montgomery-Åsberg Depression Rating Scale (MADRS)
The scale consists of 10 items rated from 0 to 6. A score between 0 and 6 indicates euthymia, a score between 7 and 19 mild depression, a score between 20 and 34 moderate depression and a score above 34 severe depression.
Measured: 1 month
suicidal ideation at 7 days after IV ketamine
number of hospitalization or ER visit for suicidal ideation
Measured: 7 days
suicidal behavior at 1 month after IV ketamine
number of suicide attempts (confirmed, aborted, interrupted)
Measured: 1 month
suicidal behavior at 3 months after IV ketamine
number of suicide attempts (confirmed, aborted, interrupted)
Measured: 3 months
suicidal ideation at 1 month after IV ketamine
number of hospitalization or ER visit for suicidal ideation
Measured: 1 month
suicidal ideation at 3 months after IV ketamine
number of hospitalization or ER visit for suicidal ideation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Dec 2023
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie OLIE, University Hospital, Montpellier
- Investigators
- Emilie OLIE, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806475
- Sponsor's protocol ID
- 23.11.07
- Acronym
- SKESI
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pastre M, Chancel R, Malestroit M, Courtet P, Olie E. Early Response to Ketamine for Suicidal Crisis Reduces Suicidal Events at 3 Months. J Clin Psychiatry. 2025 Jul 23;86(3):25m15829. doi: 10.4088/JCP.25m15829.
PubMed 40767760
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUSTAINED KETAMINE EFFECTIVENESS for SUICIDAL IDEATION
- ClinicalTrials.gov ID
- NCT06806475
- Acronym / sponsor ID
- SKESI / 23.11.07
- Conditions
- Depression - Major Depressive Disorder, Suicide
- Keywords
- suicide, depression, major depressive disorder, ketamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 4 Feb 2025 (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.
As part of the usual clinical activity of the Emergency and Post-Emergency Psychiatric Department, IV ketamine is used to treat suicidal crises in depressed patients hospitalized as an add-on to the treatment of depression. This infusion can be repeated.
Patients are systematically reassessed twice in the month following the last infusion, to ensure that the suicidal crisis is progressing. Psychometric assessments are part of routine care, to ensure systematic evaluation of psychopathology, intensity of depression and suicidality.
Therefore existing data were re-used from the medical records of patients who had received ketamine infusions to assess the effect of ketamine on suicidal ideation and behaviour.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated with IV ketamine in the Psychiatric Emergency and Post-Emergency Department (University Hospital, Montpellier) in context of suicidal crisis over the period from June 2022 to March 2024
Key inclusion criteria (2 listed)
- Patients treated with IV ketamine in the Psychiatric Emergency and Post-Emergency Department (University Hospital, Montpellier) in context of suicidal crisis
- over 18 y.o
Key exclusion criteria (4 listed)
- Opposition to data use
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship or curatorship)
- Subject not affiliated to a social security system
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
suicidal ideation at 7 days after IV ketamine administration
Time frame: 7 days
evolution of suicidal ideation at 7 days after IV ketamine administration in the context of a suicidal crisis using severity of suicidal ideation according to C-SSRS (COLUMBIA-SUICIDE SEVERITY RATING SCALE) The ideation severity subscale ranges from 1 to 5 (higher score indicating more severe ideation). The ideation intensity subscale includes 5 questions each ranging from 1 to 5 (higher score indication more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
8 secondary outcomes
suicidal ideation at 1 month after IV ketamine administration
Time frame: 1 month
Severity of depressive symptomatology at 7 days
Time frame: 7 days
Severity of depressive symptomatology at 1 month
Time frame: 1 month
suicidal ideation at 7 days after IV ketamine
Time frame: 7 days
suicidal behavior at 1 month after IV ketamine
Time frame: 1 month
suicidal behavior at 3 months after IV ketamine
Time frame: 3 months
suicidal ideation at 1 month after IV ketamine
Time frame: 1 month
suicidal ideation at 3 months after IV ketamine
Time frame: 3 months
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 30 Mar 2025.
- Derived from this study: PubMed 40767760Pastre M, Chancel R, Malestroit M, Courtet P, Olie E. Early Response to Ketamine for Suicidal Crisis Reduces Suicidal Events at 3 Months. J Clin Psychiatry. 2025 Jul 23;86(3):25m15829. doi: 10.4088/JCP.25m15829.
- Individual participant dataSharing planned: No
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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.
Emilie OLIE, MD PhD principal investigator
University Hospital, Montpellier
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 - Major Depressive Disorder and Suicide, run by University Hospital, Montpellier 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 2 inclusion and 4 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 30 Mar 2025. 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?
suicidal ideation at 7 days after IV ketamine administration (time frame: 7 days). 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 NCT06806475, which also lists 1 linked publication.
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 30 Mar 2025.