None listed
Conditions
Brief summary
This study is an open-label clinical trial aiming to explore the effectiveness, feasibility and tolerability of oral ketamine on suicidality. The pathology and neurobiology of suicidality will be examined via MRI and EEG as neurological measures. The primary outcome of change in suicidality will be assessed using the Beck Scale for Suicide Ideation.
Interventions
Participants will be administered a weekly sub anaesthetic dose of ketamine (oral liquid formulation) for six consecutive weeks beginning at 0.5mg/kg and titrated to 3.0mg/kg. Dosing will increase by 0.1 - 0.5mg/kg each week for participants who tolerate the previous dose, with dosing determined by a Psychiatrist. Dosing will be administered at the trial site under direct supervision of the Psychiatrist, and participants will be monitored for one hour by a Mental Health Nurse Practitioner or Men
Participants will be administered a weekly sub anaesthetic dose of ketamine (oral liquid formulation) for six consecutive weeks beginning at 0.5mg/kg and titrated to 3.0mg/kg. Dosing will increase by 0.1 - 0.5mg/kg each week for participants who tolerate the previous dose, with dosing determined by a Psychiatrist. Dosing will be administered at the trial site under direct supervision of the Psychiatrist, and participants will be monitored for one hour by a Mental Health Nurse Practitioner or Mental Health Nurse Research Officer prior to leaving the site.
Sponsors
Sunshine Coast Mind and Neuroscience - Thompson Institute, University of the Sunshine Coast
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients with chronic suicidal thoughts as the primary presenting complaint, determined by a score of greater than or equal to 6 for the 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 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)
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 (as assessed by referring general practitioner) • Liver function test (LFT) results that exceed the upper level of normal range by 3 times • Previous reaction to ketamine (as reported by referring general practitioner and participant) • Pregnant women • Breastfeeding women
Outcome results
None listed