None listed
Conditions
Brief summary
This open-label, dose-ranging clinical trial which aims to determine the feasibility, tolerability, and safety of oral ketamine (OK) for post-traumatic stress disorder. In this 10-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments (week 7; week 10) Participants (N = 50) will be receive a sub-anaesthetic dose of OK once a week over a 6-week period (according to an established titration protocol; 6 ketamine treatments in total); • All participants will be engaged with their treating doctors for the duration of the trial. • Ketamine will be used as an adjunctive treatment, meaning that participants are able to maintain or modify their current treatments under guidance of their physician. Any changes to medication will be recorded by study staff. Primary hypothesis: That a 6-week OK treatment will be efficacious in reducing PTSD symptom frequency and severity. Secondary hypotheses: That a 6-week OK treatment will be efficacious in: reducing stress, anxiety, depression, suicidal ideation; Improving cognitive, social, and occupational functioning; Improving sleep quality; Improving overall wellbeing. Additionally, this study aims to examine the cognitive, neurobiological, and neurophysiological effects of OK treatment in adult participants with PTSD. All changes outlined in this ANZCTR have been approved prior by Princes Charles Hospital Human Research Ethics Committee.
Interventions
This trial aims to determine the feasibility, tolerability, and safety of oral ketamine (OK) as a treatment for post-traumatic stress disorder (PTSD). In this 10-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments.
Participants will be administered a sub-anaesthetic oral dose of ketamine once a week for a period of 6 weeks. The initial dose will be 0.5mg per kilogram, after which dose amounts will be increased by between 0.1mg and 1mg/kg in eac
This trial aims to determine the feasibility, tolerability, and safety of oral ketamine (OK) as a treatment for post-traumatic stress disorder (PTSD). In this 10-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments. Participants will be administered a sub-anaesthetic oral dose of ketamine once a week for a period of 6 weeks. The initial dose will be 0.5mg per kilogram, after which dose amounts will be increased by between 0.1mg and 1mg/kg in each treatment, with a maximum dose of 3.0mg/kg. Upon reaching 3.0mg/kg, participants will continue at that level until the end of the treatment phase, provided they tolerate the dose, i.e. “endure the action of ketamine without any side effect or discomfort”. Oral ketamine will be administered on-site by the psychiatrist as per the dosage protocol on routine basis but can be administered by the Mental Health Nurse Practitioner (MHNP) as directed by the psychiatrist. The participants will be observed at Thompson Institute for up to two hours after the drug administration. An accountability logbook and controlled drug register (as per Queensland Governmental regulations) for ketamine will be maintained throughout the trial. If a participant is unable to attend or misses a ketamine treatment, details of the deviation will be recorded in the source documentation. Participants will be withdrawn from the study if they miss more than 2 ketamine treatments.
Sponsors
University of the Sunshine Coast Mind and Neuroscience Thompson Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
•Current PTSD diagnosis •Persons (male/female/other) aged over 18 years •Participants must be able to understand and provide consent on the Participant Information and Consent Form (PICF). •Participants must be able to tolerate the ketamine treatment, rating scales, blood testing and urinalysis in order to remain in the study and this will be monitored on an ongoing basis, as per the methodology.
Exclusion criteria
Psychiatric conditions: •Psychosis •Mania/hypomania •Acute suicidality requiring urgent psychiatric intervention •History of ketamine use disorder Physical conditions: •Participants who have history of epilepsy or unexplained seizure history. •Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100) • Body weight of >150kg •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) •Participants who are pregnant, currently breastfeeding, or who are planning a pregnancy during the trial •Participants who are simultaneously engaging in another clinical intervention trial while participating in OKTOP •Participants with a history of substance use disorder (excluding ketamine use disorder), may be eligible to participate in the study if they abstain from alcohol or illicit substance use two weeks prior to participation in the trial and for the remainder of the trial.
Outcome results
None listed