N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression
The investigators propose to assess the efficacy, feasibility, tolerability and safety of N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.
Details
Randomized, double-blind, parallel-group Phase IV trial comparing IV ketamine 0.5 mg/kg versus IV saline given before the first three right-unilateral ECT treatments in adults with severe major depressive disorder; primary outcome is time to remission (HAM-D-28).
Secondary aims examine ECT-related cognitive side effects using a neuropsychological battery at baseline, end of acute series and 3-month follow-up; safety and tolerability monitored throughout. Repeated EEG will assess functional connectivity before, during and after ECT.
Planned recruitment was 30 over 24 months; registry record indicates actual count N=17. Conducted at Massachusetts General Hospital, Boston, USA.