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.
Condition or Disease
- Non Suicidal Self Injury
Phase
Study Design
Study type: | Interventional |
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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 | |
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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 |
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Minimum Age: | 18 |
Maximum Age: | 65 |
This clinical trial is recruiting
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More Details
NCT Number: | NCT04242914 |
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Other IDs: | 0724-018-TLV |
Study URL: | https://ClinicalTrials.gov/show/NCT04242914 |
Last updated: Jun 17, 2022