Unknown statusPhase 1 / Phase 2

The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

NCT04242914 · Tel-Aviv Sourasky Medical Center

Closed to entry

Status

Not accepting participants

Phase 1 / Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Clinical measures - non suicidal self injuries symptoms
Measured over Four days prior to 1st treatment; after each intervention: 1 hour, 4 hours, 24 hours; next intervention will take place 3 days after (4 interventions altogether); 3 weeks post last intervention.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

FEMALE

Sex

Not accepted

Healthy volunteers

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).

Where

1 study site

Facility	City	Region	Country
Psychiatric Service, Tel-Aviv Sourasky Medical Center	Tel Aviv	—	Israel

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04242914 on ClinicalTrials.gov →

Last updated in the registry 2020-01-27. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

All 3 trials from Tel-Aviv Sourasky Medical Center →