None listed
Conditions
Brief summary
This longitudinal study is an extension of the Oral Ketamine Trial on Suicidality. This study is an open-label, dose-ranging clinical trial of oral ketamine. Treatment will involve administration of oral ketamine over a 12-week period for Phase 1 (OKTOS-E) and over 26 weeks for Phase 2 (OKTOS-M). 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 (BSS) and the Suicidal Ideation Attributes Scales (SIDAS) as a composite outcome
Interventions
Participants who completed the original OKTOS pilot study and who are deemed eligible based on clinical parameters will be invited to participate in the two-phase extension study.
The extension study will involve delivery of oral ketamine over a 12-week period (maximum) for Phase 1 (OKTOS-E) and over 26 weeks (maximum) for Phase 2 (OKTOS-M). The same participants will be involved in both phases of the trial. There may be a break of up to 10 days between commencement of Phase 2 to allow for comp
Participants who completed the original OKTOS pilot study and who are deemed eligible based on clinical parameters will be invited to participate in the two-phase extension study. The extension study will involve delivery of oral ketamine over a 12-week period (maximum) for Phase 1 (OKTOS-E) and over 26 weeks (maximum) for Phase 2 (OKTOS-M). The same participants will be involved in both phases of the trial. There may be a break of up to 10 days between commencement of Phase 2 to allow for completion of MRI and EEG data collection at the end of Phase 1 (MRI and EEG to be conducted within +1 – 10 days of final treatment). Completion of MRI and EEG data at the end of Phase 2 may occur between +1 – 10 days of final treatment. During both study phases, participants will be administered a sub-anaesthetic dose of oral ketamine on treatment days. The ketamine will be administered as an oral liquid formulation, in a dose ranging between 0.5 - 3.0 mg/kg. The ketamine will be administered by the psychiatrist, or the Mental Health Nurse Practitioner (under the direction of the psychiatrist). The dose administered at each treatment timepoint during OKTOS-E and OKTOS-M will be the dose found to be most tolerable for the individual participant during their participation in OKTOS. There will be one to four weeks between each treatment day, depending on individual participant’s clinical needs. The first interval between treatments will be two weeks. OKTOS-E (phase 1) participants will be administered between 4 - 11 doses of ketamine during this phase. OKTOS-M (phase 2) participants will be administered between 7 - 26 doses of ketamine during this phase. To improve intervention fidelity, ketamine is administered as a liquid and consumed in front of clinicians, with onsite monitoring immediately post-consumption of the treatment. Participants will be given treatment appointment times and reminders in advance and will have contact with nursing staff in between treatments. To further increase treatment adherence, participants are provided ongoing psychoeducation regarding the intervention and likely transient side-effects.
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
Participant Inclusion Criteria for OKTOS-E (Phase 1): • Participants must have previously completed the Oral Ketamine Trial on Suicidality (OKTOS) (Bellberry Limited Application ID 2017-12-982) 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 Scale for Suicidal Ideation (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 (i.e. methods resulting in a low failure rate [less than 1% per year]) and/or the inability to become pregnant through age or surgical sterilization. • 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 the Oral Ketamine Trial on Suicidality (OKTOS) (Bellberry Limited Application ID 2017-12-982) and the Extended Oral Ketamine Trial on Suicidality (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 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 (i.e. methods resulting in a low failure rate [less than 1% per year]) and/or the inability to become pregnant through age or surgical sterilization. • 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 (as assessed by referring general practitioner) • Liver function test (LFT) results out of normal range, as specified below: • ALT: >135 U/L • AST: >123 U/ • GAMMA GT (GGT) - male participants: >210 U/L • GAMMA GT (GGT) – female participants: >135 U/L • TOTAL BILIRUBIN (BIT): >60 umol/L • ALBUMIN (A): <25g/L and >150g/L • ALK PHOS (ALP): >345 U/L • Previous reaction to ketamine (as reported by referring general practitioner and participant) • Pregnant women • Breastfeeding women • Experiencing any adverse event/s (AEs) during OKTOS or OKTOS-E • Experiencing any unexpected adverse reaction/s (UARs) during OKTOS or OKTOS-E • Experiencing any serious adverse event/s (SAEs) during OKTOS or OKTOS-E • Experiencing any known but intolerable side effects during OKTOS or OKTOS-E
Outcome results
None listed