Effects of Ketamine in the Acute Phase of Suicidal Ideation

• Status: Completed
• Trial end date: 2019-03-26
• Target enrollment: 0
• Participant gender: All

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 the BSS hetero questionnaire, in patients hospitalized for suicide risk.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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