Clinical TrialSuicidalityKetaminePlaceboKetaminePlaceboKetaminePlaceboUnknown status

The Effect of Ketamine on Mechanises Underlying Suicidal Ideation and Drug-resistant Major Depression

Double‑blind, randomised, parallel Phase III trial (n=100) comparing daily oral sub‑anesthetic ketamine for 21 days versus placebo in patients after a suicide attempt; includes fMRI mechanistic substudy and a healthy volunteer crossover (n≈40) with IV ketamine.

Target Enrollment
100 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

This is a randomized, triple‑blind, placebo‑controlled parallel trial evaluating daily oral sub‑anesthetic ketamine for 21 days versus oral placebo in patients admitted after a suicide attempt; primary aim is rapid reduction in suicidal ideation.

A subset of patient participants will undergo IV ketamine and fMRI before and after the first dose to probe mechanisms relating embodied self and emotion; outcomes include suicide and depression scales and neuroimaging measures.

A secondary healthy‑volunteer crossover (≈40 participants) will receive IV ketamine and IV saline in two sessions (1–6 weeks apart) with vRHI and pain perception tasks to investigate mechanistic effects.

Study Protocol

Preparation

sessions

Dosing

21 sessions

Integration

sessions

Study Arms & Interventions

Ketamine (suicidal)

experimental

Daily oral sub‑anesthetic ketamine for 21 days in patients after a suicide attempt; parallel randomised vs placebo; some subjects undergo IV/fMRI substudy.

Interventions

  • Ketamine
    via Oral• daily• 21 doses total

    Daily outpatient sub‑anesthetic oral ketamine for 21 days; dose per protocol (not specified here).

Placebo (suicidal)

inactive

Daily oral placebo for 21 days (saline comparator).

Interventions

  • Placebo
    via Oral• daily• 21 doses total

    Oral saline placebo for 21 days.

Ketamine (TRD)

experimental

Daily oral ketamine for 21 days in treatment‑resistant depression subgroup.

Interventions

  • Ketamine
    via Oral• daily• 21 doses total

    Daily outpatient oral ketamine; dose per protocol (not specified here).

Placebo (TRD)

inactive

Daily oral placebo for 21 days in TRD subgroup.

Interventions

  • Placebo
    via Oral• daily• 21 doses total

    Oral saline placebo.

Healthy crossover

experimental

Healthy participants (n≈40) crossover: IV ketamine vs IV saline in two sessions 1–6 weeks apart; vRHI and pain tasks with fMRI substudy.

Interventions

  • Ketamine
    via IV• two sessions• 2 doses total

    IV ketamine; sessions separated 1–6 weeks; vRHI and pain tasks; mechanistic fMRI substudy.

  • Placebo
    via IV• two sessions• 2 doses total

    IV saline comparator.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Suicidal Ideation group:
  • 1. Any person admitted to the emergency department after a suicide attempt, defined as requiring medical intervention (surgical or pharmacological treatment or observation).
  • 2. Need for medical intervention defined by the ER physician.
  • 3. Ages 18–65.
  • Depression (drug‑resistant) group:
  • 1. Diagnosed with major depression according to DSM criteria.
  • 2. Ongoing depression despite treatment with at least two antidepressants in adequate dosages and for longer than three weeks.
  • 3. Ages 18–65.
  • Romantic relationship breakup (healthy participants):
  • 1. Experienced a meaningful romantic relationship break‑up within the past 12 months.

Exclusion Criteria

  • Exclusion Criteria (all groups):
  • 1. Psychotic state at examination.
  • 2. Diagnosis of schizophrenia or schizoaffective disorder.
  • 3. Drug or alcohol abuse as revealed by blood/urine tests.
  • 4. Primary or secondary gain as judged by examiner.
  • 5. Patient without any pharmacological treatment at time of admission (where relevant).

Study Details

Locations

Tel Aviv Sourasky Medical Center — Tel Aviv, N/A = Not Applicable, Israel

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