AzTrials
AzTrials

Non Suicidal Self InjuryPhase 1/2NCT04242914

The Effect of Intravenous Ketamine on Non Suicidal Self Injuries.

A Phase 1/2 study testing Ketamine and Midazolam in people with Non Suicidal Self Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Non Suicidal Self Injury
What is being tested?
Ketamine and Midazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIsrael
Study dates
25 Feb 2019to 24 Feb 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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)

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Lior Dvorak, M.D. contact

972527360974

liordv@tlvmc.gov.il

Michal Tevet, Ms. contact

97236973685

michaltev@tlvmc.gov.il

Israel1 site, 1 recruiting

  • Psychiatric Service, Tel-Aviv Sourasky Medical Center

    Tel Aviv

    Miki Bloch, Ph.D., 972-3-6974568

    Miki Bloch, Ph.D.

    Recruiting

Other trials in Israel

About this study

Official title: The Effect of Intravenous Ketamine on Non-suicidal Self-injuries in Women Suffering From Complex Post Traumatic Stress Disorder (cPTSD)

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.

Being tested
Ketamine, Midazolam
Keywords
Ketamine, Midazolam, Non-Suicidal Self-Injury, Intravenous
Medical subject headings
Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

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

  • MidazolamDrug

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

Study groups in NCT04242914
Study groupRoleWhat they receive
Research: Ketamine + MidazolamExperimentalResearch group will receive ketamine and midazolam.
Receives: Drug: Ketamine; Drug: Midazolam
Control: MidazolamExperimentalControl group will receive midazolam.
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Clinical measures - biomarkers related to ketamine treatment - IL-6

    Changes in specific biomarkers as a result of ketamine treatment: interleukin 6 (IL-6).

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

  2. Clinical measures - biomarkers related to ketamine treatment - hsCRP

    Changes in specific biomarkers as a result of ketamine treatment: high sensitive C-Reactive Protein (hsCRP).

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

  3. Clinical measures - biomarkers related to ketamine treatment - BDNF

    Changes in specific biomarkers as a result of ketamine treatment - Brain Dendritic Neurotrophic Factor (BDNF).

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

  4. Self reported questionnaires - depressive symptoms

    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.

    Measured: 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.

  5. Self reported questionnaires - anxiety symptoms

    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.

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

  6. Self reported questionnaires - Suicidal ideation

    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.

    Measured: C-SSRS will be taken four days prior to 1st treatment.

  7. Self reported questionnaires - Suicidal ideation

    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.

    Measured: 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.

  8. Self reported questionnaires - impulsivity

    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.

    Measured: BIS-11 will be taken four days prior to 1st treatment four days; 3 weeks post last intervention.

  9. Self reported questionnaires - well being

    Patients well being will be measured by Well-Being Index (WHO 5). Higher score means greater well being.

    Measured: 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.

  10. Self reported questionnaires - Visual Analogue Scale (VAS)

    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.

    Measured: VAS will be after each intervention: 1 hour, 4 hours, 24 hours; next intervention will take place 3 days after (4 interventions altogether).

  11. Clinical measures - adverse effects

    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.

    Measured: Adverse effects questionnaire will be taken after each intervention: 1 hour, 4 hours; next intervention will take place 3 days after (4 interventions altogether).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start25 Feb 2019
  3. Primary completion24 Feb 2021 (estimated)
  4. Study completion24 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized control, double blind trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04242914
Sponsor's protocol ID
0724-018-TLV
Status last verified
Jan 2020
First submitted
9 Jan 2020
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ketamine and Midazolam in people with Non Suicidal Self Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lior Dvorak, M.D. (972527360974, liordv@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04242914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in