6/28/23, 9:52 PM ELEKT-D Pathway Feedback Search Clinical Topics Home Studies ELEKT D ELEKT D Disease Major depressive disorder Trial question Is ketamine noninferior to electroconvulsive therapy in patients with nonpsychotic treatment- resistant major depression? Study design Multi-center Open label RCT Population Characteristics of study participants 51.0% female N = 403 49.0% male 403 patients (206 female, 197 male) Inclusion criteria: patients with treatment-resistant major depression without psychosis Key exclusion criteria: pregnancy or breastfeeding; contraindication to ketamine or electroconvulsive therapy; severe medical illness or severe neurological disorder; diagnosis of major depressive disorder with psychotic features Interventions N=200 ketamine (0.5 mg/kg infusion over 40 minutes twice per week) N=203 electroconvulsive therapy (therapy given three times per week) Primary outcome Response to treatment 55.4 55.4 % https://web.pathway.md/studies/recAXLBvhj2yRV9Zw 1/2 6/28/23, 9:52 PM ELEKT-D Pathway 41.2 41.5 % 27.7 % Difference not exceeding nonferiority margin 13.8 % 0.0 % Ketamine Electroconvulsive therapy Difference not exceeding nonferiority margin in response to treatment (55.4% vs. 41.2%; AD 14.2%, 95% CI 3.9 to 24.2) Secondary outcomes No significant difference in Montgomery-Asberg Depression Rating Scale-based response (50.8% vs. 41.4%; AD 9.3%, 95% CI -0.9 to 19.4) Significant increase in Global Self-Evaluation of Memory score at end-of-treatment (4.2 vs. 3.2; AD 1.1, 95% CI 0.9 to 1.2) No significant difference in improvement in 16-item Quality-of-Life Scale score (12.3 vs. 12.9; AD -0.6, 95% CI -3.4 to 2.1) Safety outcomes No significant difference in 1 adverse event. Significant difference in muscle pain or weakness (0.5% vs. 5.3%). Conclusion In patients with treatment-resistant major depression without psychosis, ketamine was noninferior to electroconvulsive therapy with respect to response to treatment. Reference Amit Anand, Sanjay J Mathew, Gerard Sanacora et al. Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression. N Engl J Med. 2023 May 24. Online ahead of print. Open reference URL https://web.pathway.md/studies/recAXLBvhj2yRV9Zw 2/2