The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

STATUS

Recruiting
participants needed

30
sponsor

Tel-Aviv Sourasky Medical Center

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Updated on 19 February 2024

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suicidal

psychosis

ketamine

midazolam

depression

hypertension

arrhythmia

drug abuse

sedative

drugs of abuse

Summary

Show definitions

Non-suicidal self-injuries (NSSI) is a deliberate harm a person causes directly to their body, resulting in structural or functional damage, without suicidal ideation. This behavior is related to unbearable internal stress, thoughts, or mental pain, which NSSI assists in dismantling. To date, there is no generally approved therapy that assists in lowering NSSI. Ketamine is a sedative drug, presently at the focus of psychopharmacologic research, which was found to improve depression, when taken orally, and lower suicidal ideation, when given intravenously. Our aim is to assess the efficiency of intravenous ketamine in decreasing NSSI symptomology in women with a history of childhood sexual abuse presenting with such behavior. Participants will be recruited among hospitalized patients from the Tel-Aviv Medical Central psychiatric ward, who will present with either NSSI urges or behavior. The study design is a randomized control, double blind trial. Each patient will be assessed before, during, and after the trial by physical examination, blood tests and questionnaires. The patients will be randomized into research group (treated by ketamine and midazolam intravenously) or control group (treated intravenously via midazolam only). Our hypothesis is that treatment by intravenous ketamine will lower NSSI symptomology, and enable optimal treatment while being hospitalized.

Details

Condition	Non Suicidal Self Injury
Age	18years - 65years
Treatment	Ketamine, midazolam
Clinical Study Identifier	NCT04242914
Sponsor	Tel-Aviv Sourasky Medical Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18-65 y.o
	Women
	Hospitalized
	Willing to sign the informed consent
	Fluent in Hebrew
	Reporting unbearable urge for self-injury and / or active NSSI behaviour) upon admittance, or on the preceding week
	Not pregnant, nor breast feeding
	No history of drugs abuse
	No previous treatment with ketamine
	No psychotic disorder, nor severe physical condition (including unstable hypertension, arrhythmias or severe / active neurological condition)
Exclusion Criteria
	Age < 18 year; Age >65 years
	Men
	Inability to sign informed consent, Non-Fluent in Hebrew
	No report of NSSI, last NSSI event took place further than preceding week
	Active pregnancy or breast feeding
	History of drugs abuse
	Previous trial involving ketamine treatment during which no improvement was observed
	Presence of psychotic disorder, and / or major physical condition (including unstable hypertension, arrhythmias or severe / active neurological condition)

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The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.