Clinical TrialSuicidalityKetamineCompleted

An open-label clinical trial of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist, with weekly dosing over six weeks, in 25-50 patients who are experiencing chronic suicidal ideation.

Open-label, non-randomised Phase II study (n=40) of weekly supervised oral ketamine (start 0.5 mg/kg, titrate to 3.0 mg/kg) over six weeks for patients with chronic suicidal ideation.

Target Enrollment
40 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This open-label Phase II study evaluates the efficacy, feasibility and tolerability of a supervised oral ketamine liquid formulation given once weekly for six weeks with psychiatrist-determined titration from 0.5 mg/kg to a maximum of 3.0 mg/kg.

Primary outcome is change in suicidality measured by the Beck Scale for Suicide Ideation (BSS). Secondary assessments include MRI and EEG at baseline, Week 6 and Week 10 to explore neural correlates and glutamatergic changes, plus safety monitoring (vitals, AEs, LFTs).

Study Protocol

Preparation

sessions

Dosing

6 sessions
60 min each

Integration

sessions

Study Arms & Interventions

Oral ketamine

experimental

Weekly supervised oral sub-anaesthetic ketamine titrated over six weeks, administered at site under psychiatrist supervision with on-site monitoring.

Interventions

  • Ketamine0.5 - 3 mg/kg
    via Oral• weekly• 6 doses total

    Start 0.5 mg/kg and titrate 0.1–0.5 mg/kg weekly to 3.0 mg/kg per psychiatrist; supervised administration with ~1 h monitoring post-dose.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Patients with chronic suicidal thoughts as the primary presenting complaint, determined by a score ≥6 on the Beck Scale for Suicide Ideation (BSS)
  • Persons (male/female/other) aged over 18 years
  • Participant to receive physical examination from Principal Investigator within 14 days prior to commencement to confirm eligibility
  • Able to understand the Participant Information Form and provide written informed consent

Exclusion Criteria

  • Persons under 18 years of age
  • Psychosis
  • Mania/hypomania
  • Acute suicidality requiring urgent psychiatric intervention
  • Uncontrolled/severe symptomatic cardiovascular disease (recent MI within 6 months; history of stroke; resting BP >150/100)
  • History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/TBI or increased intracranial pressure
  • LFTs >3× upper limit of normal
  • Previous adverse reaction to ketamine
  • Pregnant or breastfeeding women

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment40 participants
  • Timeline
    Start: 2018-08-02
    End: 2019-10-16
  • Compound
    Ketamine
  • Topic
    Suicidality

Locations

Unknown facility — Australia

Your Library