The KARMA-DEP (2) Trial explores the use of ketamine as an adjunctive therapy for people with severe depression.
Ketamine is a routinely used and relatively inexpensive anaesthetic, which is a substance that causes a loss of awareness. Ketamine is an antagonist of the N-methyl-D-asparate receptor (NMDAR) and targets the excitatory neurotransmitter glutamate. Single, slowly administered, sub-anaesthetic, intravenous infusions of ketamine bring on rapid, though short-term, antidepressant responses. They also target core symptoms of depression, including suicidal ideation. Although these findings are remarkable, a definitive role for ketamine in managing depression is not yet agreed. There are also concerns about unregulated, off-label use of ketamine and an associated lack of oversight.
Ketamine as an adjunctive therapy for Major Depression (2) - a randomised controlled trial (or the KARMA-Dep (2) Trial) is a pragmatic, randomised, controlled, parallel-group, superiority trial. This trial investigates if repeated ketamine infusions (given twice weekly, with up to eight infusions) as an adjunctive, or supporting, therapy to routine care will improve depression outcomes in people hospitalised with severe depression.
The trial also investigates if ketamine as an adjunctive therapy is associated with reduced healthcare costs and improved quality of life. Treatments prescribed by people’s treating teams are continued as usual.
The result of the proposed trial should be generalisable to people with depression hospitalised in industrialized nations, but may be applicable more internationally and to people with severe depression in general.
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Recruitment status: Recruiting
EudraCT number: 2019-003109-92
Funder: Health Research Board
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