The investigators propose to assess the efficacy, feasibility, tolerability and safety of N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.
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.
IV ketamine (0.5 mg/kg) administered before ECT; right-unilateral ECT at 5-6x seizure threshold three times per week.
Infusion given prior to first three ECT sessions.
Right unilateral ECT at 5-6x seizure threshold; 3x/week.
Routine muscle relaxant given with ECT.
Routine anesthetic agents given with ECT.
IV saline (placebo) administered before ECT; right-unilateral ECT at 5-6x seizure threshold three times per week.
IV saline placebo prior to ECT.
Right unilateral ECT at 5-6x seizure threshold; 3x/week.
Routine muscle relaxant given with ECT.
Routine anesthetic agents given with ECT.