The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

Brief 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.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Midazolam

Condition or Disease

  • Non Suicidal Self Injury

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 30 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Feb 25, 2019
Primary Completion: Feb 24, 2021
Completion Date: Feb 24, 2024
Study First Posted: Jan 27, 2020
Results First Posted: Aug 31, 2020
Last Updated: Jan 27, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Eligibility Criteria

Sex: Female
Minimum Age: 18
Maximum Age: 65

This clinical trial is recruiting

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More Details

NCT Number: NCT04242914
Other IDs: 0724-018-TLV
Study URL: https://ClinicalTrials.gov/show/NCT04242914
Last updated: Jun 17, 2022