This randomised, double-blind, midazolam-controlled, multicentre trial (n=98) will investigate the efficacy and safety of low-dose subcutaneous ketamine in adults with bipolar depression.
The trial, named the Kite Trial, aims to determine if a 3-week course of low-dose ketamine administered twice weekly can effectively reduce depression symptoms in individuals with moderate-to-severe bipolar disorder. Participants, aged 18 and over, must be currently experiencing a major depressive episode and on stable mood-stabilising medication.
The study will involve two phases: a 3-week randomised controlled trial where participants will receive either ketamine or an active placebo (midazolam), followed by a 3-week open-label extension phase for those who continue.
Outcomes will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS), and additional assessments will track safety and effectiveness.
The study is funded by the NHMRC’s Million Minds Mission and conducted by The University of Melbourne at multiple sites across Australia.
The Kite Trial is expected to begin recruitment in late June 2024, with the final participant follow-up anticipated by September 2027.
Trial Details
This randomised controlled trial (RCT) investigates the effects of low-dose subcutaneous ketamine in a 3-week treatment phase. Participants will receive ketamine (starting at 0.6 mg/kg) or an active placebo (midazolam) twice a week, with doses adjusted based on response and tolerability. Each participant may receive up to 6 treatments during this period. The RCT phase is followed by a 3-week open-label extension where those previously receiving ketamine can continue at their final RCT dose level. The study will assess changes in depression symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS) and evaluate tolerability with additional scales.NCT Number ACTRN12624000789561