Clinical trial NCT04242914: The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.
Official title: The Effect of Intravenous Ketamine on Non-suicidal Self-injuries in Women Suffering From Complex Post Traumatic Stress Disorder (cPTSD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non Suicidal Self Injury
Keywords: Ketamine, Midazolam, Non-Suicidal Self-Injury, Intravenous
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-01-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control, double blind trial
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Clinical measures - non suicidal self injuries symptoms
timeFrame: 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:
measure: Clinical measures - biomarkers related to ketamine treatment - IL-6
timeFrame: Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.
measure: Clinical measures - biomarkers related to ketamine treatment - hsCRP
timeFrame: Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.
measure: Clinical measures - biomarkers related to ketamine treatment - BDNF
timeFrame: Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention.
measure: Self reported questionnaires - depressive symptoms
timeFrame: 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.
measure: Self reported questionnaires - anxiety symptoms
timeFrame: DASS-21 will be taken four days prior to 1st treatment; 3 weeks post last intervention.
measure: Self reported questionnaires - Suicidal ideation
timeFrame: C-SSRS will be taken four days prior to 1st treatment.
measure: Self reported questionnaires - Suicidal ideation
timeFrame: SSI 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.
measure: Self reported questionnaires - impulsivity
timeFrame: BIS-11 will be taken four days prior to 1st treatment four days; 3 weeks post last intervention.
measure: Self reported questionnaires - well being
timeFrame: WHO-5 will be taken four days prior to 1st treatment; 4 hour after 2nd intervention; 7 days later, 4 hour after 4th intervention; 3 weeks post last intervention.
measure: Self reported questionnaires - Visual Analogue Scale (VAS)
timeFrame: VAS will be after each intervention: 1 hour, 4 hours, 24 hours; next intervention will take place 3 days after (4 interventions altogether).
measure: Clinical measures - adverse effects
timeFrame: Adverse effects questionnaire will be taken after each intervention: 1 hour, 4 hours; next intervention will take place 3 days after (4 interventions altogether).
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Psychiatric Service, Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Tel Aviv University
name: Miki Bloch, Prof.
role: PRINCIPAL_INVESTIGATOR
References: