NCT06806475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

March 30, 2025

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

January 28, 2025

Last Update Submit

March 25, 2025

Conditions

Keywords

suicidedepressionmajor depressive disorderketamine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • suicidal ideation at 1 month after IV ketamine administration

    1 month

  • Severity of depressive symptomatology at 7 days

    7 days

  • Severity of depressive symptomatology at 1 month

    1 month

  • suicidal ideation at 7 days after IV ketamine

    7 days

  • suicidal behavior at 1 month after IV ketamine

    1 month

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Montpellier

Montpellier, 34000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SuicideDepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Emilie OLIE, MD PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 4, 2025

Study Start

December 1, 2023

Primary Completion

September 23, 2024

Study Completion

September 23, 2024

Last Updated

March 30, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations