Ketamine as an Adjunctive Therapy for Major Depression (2) (KARMA-Dep2)

This parallel-group, randomised, controlled trial (n=104) investigates the efficacy of ketamine as an adjunctive therapy for major depression (MDD).

Referred to as KARMA-Dep (2), the trial, initiated on September 13, 2021, and estimated to conclude by December 1, 2024, aims to assess the mood-rating score difference between ketamine and midazolam over a four-week course of twice-weekly infusions.

Patients, aged 18 and older, admitted to St Patrick’s University Hospital for major depressive episode treatment, will be randomly allocated to either ketamine or midazolam. The primary outcome measure is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score 24 hours after the final infusion, with a 24-week follow-up. Both groups will receive usual inpatient care during the trial, and outcomes will be assessed through various scales and measures. Declan M McLoughlin, PhD, leads the study conducted in Dublin, Ireland.

Trial Details

Pragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the trial is to assess the mood-rating score difference between ketamine and midazolam from before the first infusion to 24 hours after the final infusion, supplemented by a 95% confidence interval. There will also be a 24-week follow-up after the final infusion session.

NCT Number NCT04939649

Data attribution

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