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The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

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ClinicalTrials.gov Identifier: NCT04242914
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE January 9, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE February 25, 2019
Estimated Primary Completion Date February 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
Clinical measures - non suicidal self injuries symptoms [ Time Frame: 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. ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • Clinical measures - biomarkers related to ketamine treatment - IL-6 [ Time Frame: Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention. ]
    Changes in specific biomarkers as a result of ketamine treatment: interleukin 6 (IL-6).
  • Clinical measures - biomarkers related to ketamine treatment - hsCRP [ Time Frame: Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention. ]
    Changes in specific biomarkers as a result of ketamine treatment: high sensitive C-Reactive Protein (hsCRP).
  • Clinical measures - biomarkers related to ketamine treatment - BDNF [ Time Frame: Four days prior to 1st treatment; 1 hour after 2nd intervention; 7 days later, 1 hour after 4th intervention; 3 weeks post last intervention. ]
    Changes in specific biomarkers as a result of ketamine treatment - Brain Dendritic Neurotrophic Factor (BDNF).
  • Self reported questionnaires - depressive symptoms [ Time Frame: 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. ]
    Changes in depressive symptoms will be measured by Back Depression Inventory (BDI). Score scale from 1 to 40 points, higher score means more severe depression.
  • Self reported questionnaires - anxiety symptoms [ Time Frame: DASS-21 will be taken four days prior to 1st treatment; 3 weeks post last intervention. ]
    Changes in anxiety symptoms will be measured by Depression, Anxiety and Stress Scale (DASS-21 Items). Score scale from 0 to 63 points, higher score means more severe anxiety symptoms.
  • Self reported questionnaires - Suicidal ideation [ Time Frame: C-SSRS will be taken four days prior to 1st treatment. ]
    Changes in suicidal ideation will be measured by Columbia Suicide Severity Rating Scale (C-SSRS). This questionnaire assess severity of suicidal ideation, attempts and outcomes of attempted suicide.
  • Self reported questionnaires - Suicidal ideation [ Time Frame: 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. ]
    Changes in suicidal ideation will be measured by Scale for Suicidal Ideation (SSI). Score scale from 0 to 38 points, higher score means increased severity of suicidal ideation.
  • Self reported questionnaires - impulsivity [ Time Frame: BIS-11 will be taken four days prior to 1st treatment four days; 3 weeks post last intervention. ]
    Changes in impulsive behavior will be measured by Barratt Impulsiveness Scale (BIS-11). This questionnaire assess impulsive behavior, with 30 items, including motor, attention and non-planning contributors. The factors are scored directly and reversibly, hence each factor assessed independently.
  • Self reported questionnaires - well being [ Time Frame: 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. ]
    Patients well being will be measured by Well-Being Index (WHO 5). Higher score means greater well being.
  • Self reported questionnaires - Visual Analogue Scale (VAS) [ Time Frame: VAS will be after each intervention: 1 hour, 4 hours, 24 hours; next intervention will take place 3 days after (4 interventions altogether). ]
    During the treatments, there will be an on going assessment by visual analogue scale, composed of items regarding symptomatology of non suicidal self-injuries, suicidality, Depression and anxiety.
  • Clinical measures - adverse effects [ Time Frame: Adverse effects questionnaire will be taken after each intervention: 1 hour, 4 hours; next intervention will take place 3 days after (4 interventions altogether). ]
    During the treatments, the patient will be assessed for adverse effects of the infusion by ketamine side effects scale, including physical symptoms and psychotic symptoms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.
Official Title  ICMJE The Effect of Intravenous Ketamine on Non-suicidal Self-injuries in Women Suffering From Complex Post Traumatic Stress Disorder (cPTSD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized control, double blind trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Blinded participants and investigator.
Primary Purpose: Treatment
Condition  ICMJE Non Suicidal Self Injury
Intervention  ICMJE
  • Drug: Ketamine
    Intravenous Ketamine, dose 0.5mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.
  • Drug: Midazolam
    Intravenous Midazolam, dose 0.03mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.
Study Arms  ICMJE
  • Experimental: Research: Ketamine + Midazolam
    Research group will receive ketamine and midazolam.
    Interventions:
    • Drug: Ketamine
    • Drug: Midazolam
  • Experimental: Control: Midazolam
    Control group will receive midazolam.
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 24, 2024
Estimated Primary Completion Date February 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lior Dvorak, M.D. 972527360974 liordv@tlvmc.gov.il
Contact: Michal Tevet, Ms. 97236973685 michaltev@tlvmc.gov.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04242914
Other Study ID Numbers  ICMJE 0724-018-TLV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tel-Aviv Sourasky Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miki Bloch, Prof. Tel Aviv University
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP