Extended and Maintenance Oral Ketamine Trial on Suicidality
- Conditions
- Chronic suicidalityMental Health - Suicide
- Registration Number
- ACTRN12618001937202
- Lead Sponsor
- Sunshine Coast Mind and Neuroscience - Thompson Institute, University of the Sunshine Coast
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 8
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.
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method