Clinical TrialSuicidalityKetaminePlaceboRecruiting

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

Double-blind, randomised, placebo-controlled Phase II trial (n=128) testing a single 50 mg intranasal ketamine dose versus 4.5 mg intranasal midazolam to reduce acute suicidality in adults (18–70).

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

Detailed Description

This randomised double-blind Phase II trial compares a single intranasal 50 mg dose of ketamine (Ketalar) with 4.5 mg intranasal midazolam as an active placebo in adults presenting with acute suicidality; primary outcome is change in BSSI at 180 minutes post-dose.

Secondary outcomes include suicidality at 60 minutes, 1 day, 3 days and 1 week, depressive symptoms (MADRS), psychotomimetic symptoms (BPRS-PS), incidence of suicidal acts, biomarker analyses (BDNF, genetics) and neuroimaging (hippocampal MRS, DTI, fMRI). Blood samples are taken at baseline and 180 minutes.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

other

Study Arms & Interventions

Ketamine 50 mg

experimental

Single intranasal 50 mg ketamine dose (Ketalar) administered acutely.

Interventions

  • Ketamine50 mg
    via Other• single dose• 1 doses total

    Intranasal administration (Ketalar)

Midazolam 4.5 mg

active

Single intranasal 4.5 mg midazolam as active placebo comparator.

Interventions

  • Placebo4.5 mg
    via Other• single dose• 1 doses total

    Intranasal midazolam 4.5 mg (active placebo)

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Acute suicidality (rapid increase in suicidal ideation/behaviour in last 24 hours)
  • Beck Scale for Suicide Ideation (BSSI) score ≥ 7
  • Age 18–70 years
  • Able and willing to provide informed consent

Exclusion Criteria

  • Psychosis or a diagnosis of schizophrenia or other psychotic disorder
  • History of PCP or ketamine addiction/misuse
  • Under the influence of GHB at screening
  • Blood alcohol concentration (BAC) > 0.05%
  • Clinically significant or unstable cardiovascular, gastrointestinal, pulmonary, renal, hepatic, endocrine or haematological disorder, recent myocardial infarction, complex surgical problems requiring immediate attention
  • Known hypersensitivity to ketamine
  • Concomitant use of selegiline
  • Severe nasal congestion or nasal polyps
  • Pregnancy or breastfeeding
  • Women not using reliable contraception
  • Unable to complete questionnaires
  • Unwilling or unable to provide informed consent
  • Prior participation in this study

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment128 participants
  • Timeline
    Start: 2018-07-23
    End: 2024-12-30
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Netherlands

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