The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

NCT ID: NCT04242914

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2024-02-24

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.

Conditions

Non Suicidal Self Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Research: Ketamine + Midazolam

Research group will receive ketamine and midazolam.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Intravenous Ketamine, dose 0.5mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.

Midazolam

Intervention Type: DRUG

Intravenous Midazolam, dose 0.03mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.

Control: Midazolam

Control group will receive midazolam.

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Intravenous Midazolam, dose 0.03mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.

Interventions

Ketamine

Intravenous Ketamine, dose 0.5mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.

Intervention Type: DRUG

Midazolam

Intravenous Midazolam, dose 0.03mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miki Bloch, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

Psychiatric Service, Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Lior Dvorak, M.D.

Role: CONTACT

liordv@tlvmc.gov.il

972527360974

Michal Tevet, Ms.

Role: CONTACT

michaltev@tlvmc.gov.il

97236973685

Facility Contacts

Miki Bloch, Ph.D.

Role: primary

972-3-6974568

Other Identifiers

0724-018-TLV

Identifier Type: -

Identifier Source: org_study_id