None listed
Conditions
Brief summary
This study aims to explore neurobiological and blood-based biomarkers that may indicate response to ketamine and determine changes in PTSD symptoms. In doing so, the study also aims to establish the evidence base for precision medical care for the use of ketamine as a treatment for Australian Veterans with TRD and PTSD.
Interventions
Ketamine infusion therapy delivered in two phases: Phase one: Participants will receive six (6) initial intravenous ketamine infusions across two weeks. These initial six infusions are delivered on a Monday-Wednesday-Friday basis across the two weeks. Each infusion will be provided over a 40-minute timespan. In the first infusion, an intravenous ketamine drip will be initiated for a total dose of 0.2 - 0.5 mg/kg. This initial dose is determined by the treating anaesthetist. The dose is then titrated up in following infusion sessions, to a maximum of 1.0 mg/kg. The dosage for these following infusions is determined by the anaesthetists depending on acute clinical response to the previous infusion/s. Phase two: Participants will receive a further six (6) maintenance intravenous ketamine infusions delivered on a three-to-six weekly basis depending on response. The dosage for these infusions are determined based on which previous dose yielded the best response (i.e., the dose that is determined to have highest benefits combined with lowest side effects). The frequency of these follow-up infusions are determined by the treating team (nurse, psychiatrist, anaesthetist) depending on observed and reported clinical response after intravenous ketamine. For example, if a participant notices a return to baseline symptoms by four weeks following ketamine, the treating team will likely determine that maintenance infusions should be delivered at a three weekly basis. Infusions are delivered in a hospital setting by an anaesthetist. Hospital nursing staff will prepare infusion logistics, establish venepuncture site, monitor infusion and vital signs during and after infusion (60 minutes). Lead nurses that are involved in ongoing participant care engage in daily monitoring of the treatment: e.g., monitoring adherence to treatment, ketamine response, ketamine dosage, and adverse effects.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults who have been identified as eligible for the ReviveMed treatment program diagnosed with major depression or posttraumatic stress disorder who have not previously responded to pharmacological treatment such as Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitors (SNRI), Tricyclic antidepressants (TCAs) or Monoamine Oxidase Inhibitors (MAOI) antidepressants, or other selected anti psychotic medications.
Exclusion criteria
Research-specific exclusion criteria: 1. Inability to provide written informed consent and pass (80%) 10-item comprehension assessment related to study goals, risks, and benefits 2. Not eligible for ketamine treatment as determined by psychiatrist assessing a patient's eligibility for ReviveMed