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Completed

NCT Number: NCT06806475

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.

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Key information

Conditions

Depression - Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Montpellier

Montpellier, 34000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. suicidal ideation at 1 month after IV ketamine administration

    Time frame: 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.

  2. Severity of depressive symptomatology at 7 days

    Time frame: 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.

  3. Severity of depressive symptomatology at 1 month

    Time frame: 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.

  4. suicidal ideation at 7 days after IV ketamine

    Time frame: 7 days

    number of hospitalization or ER visit for suicidal ideation

  5. suicidal behavior at 1 month after IV ketamine

    Time frame: 1 month

    number of suicide attempts (confirmed, aborted, interrupted)

  6. suicidal behavior at 3 months after IV ketamine

    Time frame: 3 months

    number of suicide attempts (confirmed, aborted, interrupted)

  7. suicidal ideation at 1 month after IV ketamine

    Time frame: 1 month

    number of hospitalization or ER visit for suicidal ideation

  8. suicidal ideation at 3 months after IV ketamine

    Time frame: 3 months

    number of hospitalization or ER visit for suicidal ideation

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: SKESI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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