Clinical TrialTreatment-Resistant Depression (TRD)KetamineNot yet recruiting

Ketamine Infusion Therapy for Australian Veterans with Treatment Resistant Depression and Post-Traumatic Stress Disorder

Open-label, interventional single-group study (n=100) delivering six IV ketamine infusions over two weeks (induction; 0.2–0.5 mg/kg initial titrated to 1.0 mg/kg; ~40 min per infusion) followed by up to six maintenance infusions every 3–6 weeks for Australian veterans with TRD and PTSD.

Target Enrollment
100 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

This non‑randomised, open‑label study delivers an induction course of six intravenous ketamine infusions over two weeks (Mon/Wed/Fri) with doses set by the anaesthetist (initial 0.2–0.5 mg/kg, titrating to a maximum of 1.0 mg/kg) and each infusion administered over approximately 40 minutes.

Participants may receive up to six maintenance infusions every 3–6 weeks based on clinical response; infusions are delivered in a hospital setting by an anaesthetist with nursing monitoring during and for 60 minutes post‑infusion.

Outcomes include change in depression symptoms and suicidality measured at baseline, mid‑treatment and multiple follow‑up points up to approximately six months post‑induction.

Study Protocol

Preparation

sessions

Dosing

12 sessions
40 min each

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Ketamine infusion

experimental

Open-label single-group induction (6 infusions over 2 weeks) then up to 6 maintenance infusions (every 3–6 weeks) delivered IV in hospital by an anaesthetist.

Interventions

  • Ketamine0.2 - 1 mg/kg
    via IV• induction then maintenance• 12 doses total

    Induction: six infusions (Mon/Wed/Fri) over 2 weeks; initial infusion 0.2–0.5 mg/kg (determined by anaesthetist) titrated to max 1.0 mg/kg; each infusion over ~40 minutes. Maintenance: up to six infusions delivered every 3–6 weeks based on clinical response.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Adults eligible for the ReviveMed treatment program diagnosed with major depressive disorder or post‑traumatic stress disorder who have not previously responded to pharmacological treatment such as SSRIs, SNRIs, TCAs, MAOIs, or other selected antipsychotic medications.

Exclusion Criteria

  • 1. Inability to provide written informed consent and fail (≥80%) a 10‑item comprehension assessment related to study goals, risks, and benefits.
  • 2. Not eligible for ketamine treatment as determined by the treating psychiatrist for ReviveMed.

Study Details

Locations

Unknown facility — Australia

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