The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Tel-Aviv Sourasky Medical Center
Updated on 19 February 2024
suicidal
psychosis
ketamine
midazolam
depression
hypertension
arrhythmia
drug abuse
sedative
drugs of abuse

Summary

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 IdentifierNCT04242914
SponsorTel-Aviv Sourasky Medical Center
Last Modified on19 February 2024

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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