The Study of Ketamine for Youth Depression (SKY-D): study protocol for a randomised controlled trial of low-dose ketamine for young people with major depressive disorder.

Autor: Schwartz OS; Department of Psychiatry, University of Melbourne, Melbourne, Australia. orli@unimelb.edu.au.; Orygen, Melbourne, Australia. orli@unimelb.edu.au.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia. orli@unimelb.edu.au., Amminger P; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Baune BT; Department of Psychiatry, University of Melbourne, Melbourne, Australia.; Department of Psychiatry, University of Münster, Münster, Germany.; The Florey Institute of Neuroscience and Mental Health, Melbourne, Australia., Bedi G; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Berk M; Orygen, Melbourne, Australia.; Deakin University, IMPACT, The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia., Cotton SM; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Daglas-Georgiou R; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Glozier N; Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.; Australian Research Council Centre of Excellence for Children and Families Over the Life Course, Sydney, Australia.; Professor Marie Bashir Centre, Royal Prince Alfred Hospital, Sydney, Australia., Harrison B; Department of Psychiatry, University of Melbourne, Melbourne, Australia., Hermens DF; Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia., Jennings E; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Lagopoulos J; Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia.; Thompson Brain and Mind Healthcare, Sunshine Coast, Australia., Loo C; School of Psychiatry, University of New South Wales, Sydney, Australia.; Black Dog Institute, Sydney, Australia., Mallawaarachchi S; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Martin D; Black Dog Institute, Sydney, Australia.; School of Clinical Medicine, University of New South Wales, Sydney, Australia., Phelan B; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Read N; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Rodgers A; The George Institute for Global Health, University of New South Wales, Sydney, Australia., Schmaal L; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Somogyi AA; School of Biomedicine, University of Adelaide, Adelaide, Australia., Thurston L; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia., Weller A; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia.; Victorian Department of Health, Melbourne, Australia., Davey CG; Department of Psychiatry, University of Melbourne, Melbourne, Australia.; Orygen, Melbourne, Australia.; Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Oct 24; Vol. 24 (1), pp. 686. Date of Electronic Publication: 2023 Oct 24.
DOI: 10.1186/s13063-023-07631-3
Abstrakt: Background: Existing treatments for young people with severe depression have limited effectiveness. The aim of the Study of Ketamine for Youth Depression (SKY-D) trial is to determine whether a 4-week course of low-dose subcutaneous ketamine is an effective adjunct to treatment-as-usual in young people with major depressive disorder (MDD).
Methods: SKY-D is a double-masked, randomised controlled trial funded by the Australian Government's National Health and Medical Research Council (NHMRC). Participants aged between 16 and 25 years (inclusive) with moderate-to-severe MDD will be randomised to receive either low-dose ketamine (intervention) or midazolam (active control) via subcutaneous injection once per week for 4 weeks. The primary outcome is change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) after 4 weeks of treatment. Further follow-up assessment will occur at 8 and 26 weeks from treatment commencement to determine whether treatment effects are sustained and to investigate safety outcomes.
Discussion: Results from this trial will be important in determining whether low-dose subcutaneous ketamine is an effective treatment for young people with moderate-to-severe MDD. This will be the largest randomised trial to investigate the effects of ketamine to treat depression in young people.
Trial Registration: Australian and New Zealand Clinical Trials Registry ID: ACTRN12619000683134. Registered on May 7, 2019. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377513 .
(© 2023. BioMed Central Ltd., part of Springer Nature.)
Databáze: MEDLINE
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