Randomised, single-blind (assessors) parallel trial (actual n=32) comparing curated music versus no music during six 40-minute IV ketamine infusions (0.5 mg/kg) in treatment-resistant depression; primary outcome is systolic blood pressure change during infusions.
Randomised, assessor-blinded, single-centre study comparing curated music to no-music usual care during a course of six low-dose IV ketamine infusions (0.5 mg/kg) over four weeks in participants with treatment-resistant unipolar or bipolar depression.
The primary outcome is change in systolic blood pressure from infusion start to 40 minutes (end of infusion). Secondary outcomes include repeated measures of mood, anxiety, suicidality, psychological and physical pain, and aspects of the treatment experience.
Music is delivered via headphones selected with participant input; infusion tolerability and haemodynamic responses are compared between groups with matched clinician contact time.
Curated music via headphones during each ketamine infusion (6 infusions over 4 weeks).
0.5 mg/kg IV infusion over 40 minutes per session.
Curated music via headphones starting at infusion commencement and ending ~55 minutes later; selection discussed pre-infusion.
No music during ketamine infusions; contact time matched.
0.5 mg/kg IV infusion over 40 minutes per session; music not permitted.