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

Autor: Franca M. Placenza, Pierre Blier, Elizabeth Kamler, Jane A. Foster, Jean Blier, Sidney H. Kennedy, Stéphane Richard-Devantoy, Stefanie Hassel, Lisa McMurray, Natalia Jaworska, Zahra Moazamigoudarzi, Roumen Milev, Gustavo H. Vazquez, Susan Rotzinger, Keith Ho, Venkat Bhat, Jennifer L. Phillips, Gustavo Turecki
Rok vydání: 2020
Předmět:
Zdroj: BMC Psychiatry, Vol 20, Iss 1, Pp 1-11 (2020)
BMC Psychiatry
ISSN: 1471-244X
DOI: 10.1186/s12888-020-02672-3
Popis: Background Recent evidence underscores the utility of rapid-acting antidepressant interventions, such as ketamine, in alleviating symptoms of major depressive episodes (MDE). However, to date, there have been limited head-to-head comparisons of intravenous (IV) ketamine infusions with other antidepressant treatment strategies in large randomized trials. This study protocol describes an ongoing multi-centre, prospective, randomized, crossover, non-inferiority trial comparing acute treatment of individuals meeting diagnostic criteria for a major depressive episode (MDE) with ketamine and electroconvulsive therapy (ECT) on efficacy, speed of therapeutic effects, side effects, and health care resource utilization. A secondary aim is to compare a 6-month maintenance strategy for ketamine responders to standard of care ECT maintenance. Finally, through the measurement of clinical, cognitive, neuroimaging, and molecular markers we aim to establish predictors and moderators of treatment response as well as treatment-elicited effects on these outcomes. Methods Across four participating Canadian institutions, 240 patients with major depressive disorder or bipolar disorder experiencing a MDE are randomized (1:1) to a course of ECT or racemic IV ketamine (0.5 mg/kg) administered 3 times/week for 3 or 4 weeks. Non-responders ( Discussion This multi-centre study will help identify molecular, imaging, and clinical characteristics of patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy. In addition to informing clinical practice and influencing health care delivery, this trial will add to the robust platform and database of CAN-BIND studies for future research and biomarker discovery. Trial registration ClinicalTrials.gov identifier NCT03674671. Registered September 17, 2018.
Databáze: OpenAIRE
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