The aim of the project is to evaluate the NMDA-receptor-antagonist ketamine as a novel antidepressant drug for patients with major depression and to compare its effectiveness with the established antidepressant treatment electroconvulsive therapy (ECT).

Primary outcome is the proportion of patients in respective treatment arm that reach remission. 200 patients will be randomized to sub-anaesthetic iv infusions of ketamine or standard ECT. Treatment will be given three times weekly up to a maximum of 4 weeks (12 treatments). The sample size was calculated to be sufficient to statistically demonstrate non-inferiority of ketamine compared to ECT.

The antidepressive effect is evaluated with the Montgomery Åsberg Depression Rating Scale (MADRS). Neuropsychological testing, using a touchscreen-based system, is performed at baseline (prior to treatment), after the 6th treatment, within one week after treatment cession (remission) and at 2, 6 and 12 months after the last treatment. Blood samples are collected before the first treatment and 2-3 months after it ends.

The extensive cognitive testing and frequent use of rating scales in this study is important for monitoring side effects and to acquire a high resolution of the temporal characteristics of symptomatic relief for respective treatment.

Project-group members: Pouya Movahed (head of study), Joakim Ekstrand, Anders Tingström, Aki Johanson, Mikael Johansson, Lund; Mats Lindström, Jonas Åkeson, Malmö; Axel Nordenskjöld, Örebro.