EUCTR2011‐001520‐37‐SE.
Study name | Ketamine as an alternative to electroconvulsive therapy for treatment of major depressive disorder ‐ KETECT EUCTR2011‐001520‐37‐SE |
Methods | To compare the antidepressant effect of subanaesthetic ketamine with ECT. |
Participants | Principal inclusion criteria: ASA grade 1‐3 Age 18‐65 Major depressive episode according to DSM‐IV Montgomery Asberg Depression Rating Scale (MADRS) ≥ 20 Offered and accepted ECT Understands and speaks Swedish |
Interventions | Ketamine versus saline |
Outcomes | E.5.1 Primary end point(s): antidepressive effect E.5.1.1 time point(s) of evaluation of this endpoint: the assessment is made before treatment, 1 hour and 4‐5 hours after and the day after each treatment session. A major evaluation occurs after 6 treatments to determine continued participation in the study. Patients are monitored weekly for up to four weeks after treatment or at relapse |
Starting date | Date of Competent Authority Decision: 2014‐02‐14 |
Contact information | Ida.ellerstrom@gmail.com |
Notes |