Clinical TrialSuicidalityKetaminePlaceboActive not yet recruiting

Efficacy and feasibility of intranasal ketamine on acute suicidality, a double blind randomized placebo-controlled trial (Ketamine Trial for Acute suicidality, KETA)

Double-blind, randomized, placebo-controlled Phase II trial (n=112) testing a single 75 mg intranasal ketamine dose versus 4.0 mg intranasal midazolam in adults (18–70) with acute suicidality to assess anti‑suicidal efficacy and safety.

Target Enrollment
112 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Multicentre, randomized, double‑blind, placebo‑controlled trial assessing the anti‑suicidal effect of a single 75 mg intranasal ketamine dose compared with 4.0 mg intranasal midazolam in acutely suicidal adults.

Primary outcome is change in suicidality measured by the Beck Scale for Suicide Ideation (BSSI) from baseline to 180 minutes post‑dose; secondary measures include suicidality at additional timepoints, depressive symptoms (MADRS), psychotomimetic effects (CADSS, SAFTEE), CGI, and number of suicidal acts.

Ancillary investigations include neurobiological markers using MRI, MRS, DTI and fMRI, blood sampling and pharmacokinetic/pharmacogenetic assessments; safety and tolerability are monitored acutely and during follow‑up.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

Single dose intranasal ketamine (Ketalar) 75 mg vs active placebo; multicentre, double-blind, randomized, controlled.

Interventions

  • Ketamine75 mg
    via Other• single dose• 1 doses total

    Intranasal ketamine (Ketalar) 75 mg single administration.

Midazolam (active placebo)

active

Intranasal midazolam 4.0 mg as active placebo comparator.

Interventions

  • Placebo4 mg
    via Other• single dose• 1 doses total

    Intranasal midazolam 4.0 mg used as active placebo comparator; pharmaceutical form: nasal spray solution.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Adults 18–70 years; acute suicidality as defined by a rapid increase in suicidal ideation or behaviour in the past 24 hours; Beck Scale for Suicide Ideation (BSSI) score ≥7; able to give informed consent; able to complete study assessments.

Exclusion Criteria

  • 1. Prior participation in this study.
  • 2. Primary psychosis (depression with psychotic features is not exclusion per se).
  • 3. Diagnosis of schizophrenia or another primary psychotic disorder.
  • 4. History of PCP or ketamine addiction/misuse.
  • 5. Currently under influence of GHB or blood alcohol concentration (BAC) >0.05%.
  • 6. Clinically significant unstable medical disorders (infectious, immunological, cardiovascular, gastrointestinal, pulmonary, renal, hepatic, endocrine, haematological), recent myocardial infarction, significant urinary or surgical problems requiring immediate attention.
  • 7. Contraindications to ketamine (severe hypertension, recent myocardial infarction or relevant cardiac problems, severe thyroid, liver or kidney disease, epilepsy, increased intracranial pressure).
  • 8. Known hypersensitivity to ketamine.
  • 9. Concomitant use of MAO inhibitors.
  • 10. Severe nasal congestion or nasal polyps.
  • 11. Pregnancy or breastfeeding.
  • 12. Women of childbearing potential not using reliable contraception.
  • 13. Inability to complete questionnaires or provide informed consent.
  • 14. Legal incompetency regarding consent.

Study Details

  • Status
    Active not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment112 participants
  • Timeline
    Start: 2021-06-08
    End: 2024-12-31
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Netherlands

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