Skip to main content

Table 1 Inclusion and exclusion criteria for participants

From: A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol

Inclusion criteria
 • Ability to freely provide written informed consent before initiation of study related procedures.
 • Inpatients or outpatients referred to and eligible for standard ECT. Willing to accept randomization to either ECT or IV ketamine arms.
 • Males and females between 18 and 70 years of age.
 • Meet Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) [23] criteria for MDD or BP without psychotic symptoms as confirmed by the MINI International Neuropsychiatric Interview (MINI) [24].
 • Currently in a MDE confirmed by the MINI.
 • Montgomery-Åsberg Depression Rating Scale (MADRS) [22] total score of ≥26 at screening and at randomization, with no more than 20% improvement between these two visits.
 • Body mass index < 35.
 • Montreal Cognitive Assessment (MOCA) [25] score ≥ 24.
 • Ability to understand and comply with study requirements, as judged by the investigator(s).
Exclusion criteria
 • Depression secondary to stroke, cancer or other medical illnesses.
 • Prior or current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined by DSM-5 criteria [23].
 • A positive toxicology screen for drugs that are not prescribed.
 • Pregnant, breastfeeding, or of childbearing potential and not willing to use an approved method of contraception during the study.
 • Evidence of clinically relevant disease or unstable medical illness.
 • Clinically significant deviation from reference ranges in clinical laboratory tests.
 • Clinically significant electrocardiogram results as judged by the investigator(s) or cardiologist.
 • History of seizure disorder, except febrile convulsions.
 • Known history of intolerance or hypersensitivity to ketamine.