The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Non Suicidal Self Injury

Treatments: Drug: Ketamine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT04242914

0724-018-TLV

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Research: Ketamine + Midazolam

Experimental group

Description:

Research group will receive ketamine and midazolam.

Treatment:

Drug: Ketamine

Drug: Midazolam

Control: Midazolam

Experimental group

Description:

Control group will receive midazolam.

Treatment:

Drug: Midazolam