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

Suicidal Ideation

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source