The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

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

Tracking Information

• First Submitted Date: January 9, 2020
• First Posted Date: January 27, 2020
• Last Update Posted Date: January 27, 2020
• Actual Study Start Date: February 25, 2019
• Estimated Primary Completion Date: February 24, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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: Non Suicidal Self Injury

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 23, 2020): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 24, 2024
• Estimated Primary Completion Date: February 24, 2021 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lior Dvorak, M.D.; 972527360974; liordv@tlvmc.gov.il

Contact: Michal Tevet, Ms.; 97236973685; michaltev@tlvmc.gov.il

• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT04242914
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Tel-Aviv Sourasky Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Tel-Aviv Sourasky Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Miki Bloch, Prof.; Tel Aviv University

• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: January 2020