Clinical TrialSuicidalityKetamineCompleted

A longitudinal open-label, dose-ranging clinical trial to evaluate the effectiveness of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist, in patients who are experiencing chronic suicidal ideation

Longitudinal, open-label, dose-ranging extension study (n=8) evaluating oral ketamine (0.5–3.0 mg/kg oral liquid, individualized dosing) for chronic suicidal ideation across two phases (OKTOS-E and OKTOS-M).

Target Enrollment
8 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

This open-label extension invites participants from the original OKTOS pilot to receive individually titrated sub-anaesthetic oral ketamine across two phases: OKTOS-E (up to 12 weeks; 4–11 doses) and OKTOS-M (up to 26 weeks; 7–26 doses).

Primary outcome is change in suicidality measured by the Beck Scale for Suicide Ideation (BSS) and SIDAS. Exploratory outcomes include MRI/EEG measures of resting-state and glutamatergic markers collected within +1–10 days after final treatment, and safety/tolerability monitoring.

Study Protocol

Preparation

sessions

Dosing

37 sessions

Integration

sessions

Study Arms & Interventions

Oral ketamine

experimental

Individualised sub-anaesthetic oral ketamine given as liquid formulation across two extension phases (OKTOS-E and OKTOS-M).

Interventions

  • Ketamine0.5 - 3 mg/kg
    via Oral• Individualised; 1–4 weekly (first interval 2 weeks)

    Oral liquid ketamine 0.5–3.0 mg/kg administered by psychiatrist or nurse; dose chosen per participant tolerability from parent OKTOS study; OKTOS-E: 4–11 doses; OKTOS-M: 7–26 doses.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Participant Inclusion Criteria for OKTOS-E (Phase 1):
  • Participants must have previously completed the Oral Ketamine Trial on Suicidality (OKTOS) including the four-week follow-up phase.
  • Participant continues to receive a score equal to or above 6 for the Scale for Suicidal Ideation (SSI) at the completion of OKTOS OR participant receives a score >6 for the SSI at any time within 12 weeks of completing OKTOS.
  • Persons (male/female/other) aged over 18 years.
  • Participant to receive physical examination from Principal Investigator within 14 days prior to commencement of ketamine treatment to eliminate possibility of conditions outlined in exclusion criteria.
  • Participants must be able to understand the PIF and provide written informed consent on the Participant Consent Form (PCF).
  • Total avoidance of pregnancy for the duration of the study through abstinence or adequate and highly effective contraception.
  • Male participants must avoid fathering a child during the study and for 3 months following the final ketamine treatment.
  • Participant Inclusion Criteria for OKTOS-M (Phase 2):
  • Participants must have previously completed OKTOS and the Extended OKTOS-E.
  • Persons (male/female/other) aged over 18 years.
  • Participant to receive physical examination from Principal Investigator within 14 days prior to commencement of ketamine treatment.
  • Participants must be able to understand the PIF and provide written informed consent on the PCF.
  • Total avoidance of pregnancy for the duration of the study through abstinence or adequate and highly effective contraception.
  • Male participants must avoid fathering a child during the study and for 3 months following the final ketamine treatment.

Exclusion Criteria

  • Persons under 18 years of age
  • Psychosis
  • Mania/hypomania
  • Acute suicidality requiring urgent psychiatric intervention
  • Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100)
  • History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure
  • Liver function test (LFT) results out of normal range as specified: ALT >135 U/L; AST >123 U/L; GGT male >210 U/L, female >135 U/L; Total bilirubin >60 µmol/L; Albumin <25 g/L or >150 g/L; ALP >345 U/L
  • Previous reaction to ketamine
  • Pregnant women
  • Breastfeeding women
  • Experiencing any adverse event(s) during OKTOS or OKTOS-E
  • Experiencing any unexpected adverse reaction(s) during OKTOS or OKTOS-E
  • Experiencing any serious adverse event(s) during OKTOS or OKTOS-E
  • Experiencing any known but intolerable side effects during OKTOS or OKTOS-E

Study Details

  • Status
    Completed
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment8 participants
  • Timeline
    Start: 2018-12-06
    End: 2020-06-04
  • Compound
    Ketamine
  • Topic
    Suicidality

Locations

Unknown facility — Australia

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