Sustained Ketamine Effectiveness for Suicidal Ideation (SKESI)

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.

Study Overview

• Status: Completed
• Conditions: Suicide; Depression - Major Depressive Disorder

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • University Hospital, Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
suicidal ideation at 7 days after IV ketamine	number of hospitalization or ER visit for suicidal ideation	7 days
suicidal behavior at 1 month after IV ketamine	number of suicide attempts (confirmed, aborted, interrupted)	1 month
suicidal behavior at 3 months after IV ketamine	number of suicide attempts (confirmed, aborted, interrupted)	3 months
suicidal ideation at 1 month after IV ketamine	number of hospitalization or ER visit for suicidal ideation	1 month
suicidal ideation at 3 months after IV ketamine	number of hospitalization or ER visit for suicidal ideation	3 months
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.	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.	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.	1 month

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Emilie OLIE, MD PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): September 23, 2024

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: depression; major depressive disorder; ketamine; suicide
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Mood Disorders; Suicide; Suicidal Ideation; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 23.11.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No