The KITE-Dep Trial
The KITE-Dep Trial: Ketamine interleaved with electroconvulsive therapy for depression, a pragmatic randomised controlled pilot trial.
Ketamine is routinely as an anaesthetic. Ketamine acts as an antagonist of the N-methyl-D-asparate (NMDA) receptor and targets the excitatory amino acid neurotransmitter glutamate. A single infusion of low dose intravenous ketamine rapidly improves depressive symptoms with efficacy onset within one hour post infusion, peak effect sizes at 24 hours and lasting effects for depression symptom ratings of up until 5-8 days. A number of trials to date have also investigated administration of ketamine as an adjunctive treatment to electroconvulsive therapy for major depression. It is thought that the anti-depressant effects of both ketamine and ECT when combined increase recovery of patients suffering from treatment-resistant depression.
We aim to conduct a pilot trial to assess the safety of slow infusions of ketamine delivered over a period of 40 minutes interleaved with ECT on a separate day. Outcomes of this trial include: knowledge gained from the pilot trial to inform a future randomised controlled trial; safety and tolerability data on ketamine in this treatment group. This study has the potential to directly impact on clinical practice by testing a novel therapeutic strategy. Developing a new therapy for a more rapid recovery from depression will improve quality of life for patients and their families, inform health services’ treatment guidelines, raise public awareness of mental health, and could have a positive socioeconomic impact in Ireland and abroad.
ClinicalTrials.gov Identifier: NCT04082858
EudraCT number: 2018-003421-28