This interventional trial (n=140) investigates the efficacy of low-dose subcutaneous ketamine as a treatment for moderate-to-severe depression in young people aged 16-25 years.
Conducted over a 4-week period, participants receive either ketamine or a therapeutically inactive control treatment (midazolam) once a week. The primary outcome measure is the change in depression scores assessed by the MADRS at 4 weeks, with further evaluations at weeks 8 and 26 to determine sustained effects. Secondary outcomes include changes in suicidal ideation, quality of life, and biomarkers related to ketamine’s effect.
The trial employs a double-blind design, randomising participants to treatments concealed through an online system. It’s conducted in Australia and led by Orygen, the National Centre of Excellence in Youth Mental Health, with Prof. Christopher Davey as the principal investigator. Recruitment concluded in September 2023, and data collection is ongoing. Individual participant data will be available for research purposes upon request, following publication.
Trial Details
The primary aim of this research project is to determine if a 4-week course of low-dose subcutaneous ketamine is an effective treatment for young people (males and females aged 16-25 years) with moderate-to-severe depression. Participants will be randomised to receive either low-dose subcutaneous ketamine or a blinded control treatment that is therapeutically inactive (midazolam), given once a week for 4 weeks. Change in depression scores will be assessed at the end of the treatment phase at week 4, with further assessment at weeks 8 and 26 to assess whether treatment effects are sustained. We hypothesise that ketamine will be an effective treatment for moderate-to-severe depression in young people.Trial Number ACTRN12619000683134