Study design
Adult Depression, mood disorders, depressive disorder, Depression, DSM-5
The Ketamine for Adult Depression (KADS) study was a 4-week, randomised, double-blind, active-controlled, parallel-group, multicentre phase 3 trial recruited participants from six specialist mood disorders centres in Australia and one in New Zealand. The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving human subjects/patients were approved by the Sydney Local Health District (RPAH Zone) Human Research Ethics Committee (Australia; X16-0146 and HREC/16/RPAH/168) and the Southern Health and Disability Ethics Committee (New Zealand; 16/STH/104). Participants voluntarily contacted the study team or were referred to the study by their doctor. All participants provided written informed consent and were assessed by a study doctor.Main inclusion criteria were: age ≥18 years; major depressive disorder of at least 3 months’ duration, confirmed by the Structured Clinical Interview for DSM-5 Research Version; insufficient response to at least two adequate trials of antidepressant medications; any concurrent antidepressant medication at stable dosage ≥4 weeks prior to and during the RCT; and score ≥20 on the Montgomery–Åsberg Rating Scale for Depression (MADRS).