The KARMA-DEP (2) Trial
The KARMA-DEP (2) Trial: Ketamine as an adjunctive therapy for Major Depression (2) - a randomised controlled trial
Ketamine is a routinely used and relatively inexpensive anaesthetic. Ketamine is an antagonist of the N-methyl-D-asparate receptor (NMDAR) and targets the excitatory neurotransmitter glutamate. Single, slowly administered, sub-anaesthetic ketamine intravenous infusions elicit rapid, though transient, antidepressant responses and target core symptoms in treatment-resistant depression, including suicidal ideation. Although these findings are remarkable, a definitive role for ketamine in managing depression is not yet agreed and there are concerns about unregulated off-label use and associated lack of oversight.
The KARMA-Dep (2) Trial is a pragmatic, randomised, controlled, parallel-group, superiority trial. This trial investigates if repeated ketamine infusions (twice-weekly, max 8 infusions) as adjunctive therapy to routine care will improve depression outcome in patients hospitalized with severe depression. We are investigating if ketamine as an adjunctive therapy is associated with reduced health care costs and improved quality of life. The trial also examines potential biomarkers associated with depression. Treatments prescribed by patients’ treating team are continued as usual. The results of the proposed trial should be generalizable to patients with depression hospitalized in industrialized nations but may be applicable more internationally and to patients with severe depression in general.
Recruitment status: Ethical approval obtained
EudraCT number: 2019-003109-92
Funder: Health Research Board