The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

NCT04242914 | Unknown Phase 1 DMC

• 1 other identifier: 0724-018-TLV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Ketamine, Midazolam, Non-Suicidal Self-Injury, Intravenous

Outcome Measures

Primary Outcomes (1)

• Clinical measures - non suicidal self injuries symptoms

  Change in non suicidal self injuries symptoms will be measured by Brief Non-Suicidal Self-Injury Assessment (BNSSI), which assess the quality of self injuries (method of injury, time since last injury, causes of injury, motivation of self injury and bodily areas where injuries are most common).

  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.

Secondary Outcomes (11)

• Clinical measures - biomarkers related to ketamine treatment - IL-6

  Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.

• Clinical measures - biomarkers related to ketamine treatment - hsCRP

  Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.

• Clinical measures - biomarkers related to ketamine treatment - BDNF

  Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.

• Self reported questionnaires - depressive symptoms

  BDI will be taken four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.

• Self reported questionnaires - anxiety symptoms

  DASS-21 will be taken four days prior to 1st treatment; 3 weeks post last intervention.

Study Arms (2)

Research: Ketamine + Midazolam

EXPERIMENTAL

Research group will receive ketamine and midazolam.

Drug: Ketamine; Drug: Midazolam

Control: Midazolam

EXPERIMENTAL

Control group will receive midazolam.

Drug: Midazolam

Interventions

Ketamine DRUG

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

Research: Ketamine + Midazolam

Midazolam DRUG

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

Control: Midazolam; Research: Ketamine + Midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Psychiatric Service, Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Miki Bloch, Prof.

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Dvorak, M.D.

CONTACT

972527360974; liordv@tlvmc.gov.il

Michal Tevet, Ms.

CONTACT

97236973685; michaltev@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded participants and investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: randomized control, double blind trial

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 27, 2020
• Study Start: February 25, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2024
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)