A longitudinal open-label, dose-ranging clinical... — Clinical Trial Details

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.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

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

Company

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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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Spectral changes of EEG following a 6-week low-dose oral ketamine treatment in adults with major depressive disorder and chronic suicidality

Integration

Study Arms & Interventions

Oral ketamine

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details