Status:
COMPLETED
Effects of Ketamine in the Acute Phase of Suicidal Ideation
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Suicidal Ideation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using th...
Detailed Description
The secondary objectives of this study are to assess: A. The maintenance of medium-term effectiveness of ketamine on the resolution of suicidal ideation B. The evolution of the full spectrum of suic...
Eligibility Criteria
Inclusion
- French speaking patients freely hospitalized for prevention of suicide and who have a medium or high suicide risk score according to a MINI structured interview
- The patient is able to understand how the study is carried out and the tests performed
- The patient is deemed capable of giving his/her informed consent
- The patient has been correctly informed
- The patient must have given his/her informed and signed consent.
- The patient must be insured or beneficiary of a health insurance plan.
- Presence of suicidal ideation according to the SSI score (score \> 3)
- Negative pregnancy test for women of childbearing age
Exclusion
- The patient is participating in another interventional study
- Within the past three months, the patient has participated in another interventional study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
- The patient refuses to sign the consent
- The patient is not able to understand the informed consent
- Pregnancy or breastfeeding
- History of schizophrenia or other psychotic disorders
- Presence of psychotic symptoms at initial interview
- Schizoid or schizotypic personality disorder
- Positive urine screening for illicit substances, excluding cannabis
- Substance dependence in the preceding month (excluding nicotine or caffeine)
- Concomitant treatment with electroconvulsive therapy
- Unstable somatic pathology
- Clinically significant anomalies found during clinical examination, biological test or ECG
- Non-stabilized hypertension or hypertension \> 180/100
- Known or suspected contra-indication for ketamine (includes interactions): hypersensitivity to ketamine, hypertension, class IV cardiac insufficiency, history of stroke, hepatic or cutaneous porphyria, history of intracranial hypertension
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT02299440
Start Date
April 1 2015
End Date
November 21 2019
Last Update
December 1 2025
Active Locations (9)
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1
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, France, 63003
2
CHRU de Lille - Hôpital Michel Fontan
Lille, France, 59037
3
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
4
Clinique Les Sophoras
Nîmes, France, 30000