Sustained Ketamine Effectiveness for Suicidal Ideation

Completed

• Conditions: Depression - Major Depressive Disorder; Suicide

• Registration Number: NCT06806475
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-12-01
• Primary Completion: 2024-09-23
• Study Completion: 2024-09-23
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
suicidal ideation at 7 days after IV ketamine administration	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.

Secondary Outcome Measures

Name	Time	Method
Severity of depressive symptomatology at 7 days	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.
Severity of depressive symptomatology at 1 month	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.
suicidal ideation at 7 days after IV ketamine	7 days	number of hospitalization or ER visit for suicidal ideation
suicidal behavior at 1 month after IV ketamine	1 month	number of suicide attempts (confirmed, aborted, interrupted)
suicidal behavior at 3 months after IV ketamine	3 months	number of suicide attempts (confirmed, aborted, interrupted)
suicidal ideation at 1 month after IV ketamine	1 month	number of hospitalization or ER visit for suicidal ideation
suicidal ideation at 1 month after IV ketamine administration	1 month	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.
suicidal ideation at 3 months after IV ketamine	3 months	number of hospitalization or ER visit for suicidal ideation

Trial Locations

Locations (1)

University Hospital, Montpellier; 🇫🇷 Montpellier, France