This open-label, interventional trial (n=100) will investigate the effects of ketamine infusion therapy on Australian veterans with treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Participants will receive six initial intravenous ketamine infusions over two weeks (35–70mg/70kg per session), followed by up to six maintenance infusions every three to six weeks based on individual response.
The study, conducted by Zed3 Medical Group and the University of Queensland, aims to establish an evidence base for ketamine as a treatment for veterans with TRD and PTSD. It will assess changes in depression and PTSD symptoms, as well as suicidality and recovery, using standard psychological scales. Infusions will be administered in a hospital setting under the supervision of anaesthetists, with ongoing monitoring by nurses. Recruitment is expected to begin in February 2025 across multiple Australian states.
Trial Details
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.Trial Number ACTRN12624001442594