CompletedPhase 3ketamine
Effects of Ketamine in the Acute Phase of Suicidal Ideation
Sponsored by Centre Hospitalier Universitaire de Nīmes
NCT ID
NCT02299440
Target Enrollment
156 participants
Start Date
2015-04
Est. Completion
2019-11-21
About This Study
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.
Conditions Studied
Interventions
- •Baseline evaluation
- •1st perfusion of ketamine
- •1st perfusion of saline
- •Follow-up between perfusions
- •2nd perfusion of ketamine
- •2nd perfusion of saline
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility 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
Study Locations (9)
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, France
CHRU de Lille - Hôpital Michel Fontan
Lille, France
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, France
Clinique Les Sophoras
Nîmes, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
APHP - Hôpital Lariboisière
Paris, France
Centre Hospitalier Sainte-Anne
Paris, France
CMME Centre Hospitalier Sainte Anne
Paris, France
CHRU de Tours - Clinique Psychiatrique Universitaire
Saint-Cyr-sur-Loire, France