Abstract

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.

Details

Title
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
Author
Schwartz, Orli S. 1   VIAFID ORCID Logo  ; Amminger, Paul 2 ; Baune, Bernard T. 3 ; Bedi, Gillinder 2 ; Berk, Michael 4 ; Cotton, Sue M. 2 ; Daglas-Georgiou, Rothanthi 2 ; Glozier, Nick 5 ; Harrison, Ben 6 ; Hermens, Daniel F. 7 ; Jennings, Emma 2 ; Lagopoulos, Jim 8 ; Loo, Colleen 9 ; Mallawaarachchi, Sumudu 2 ; Martin, Donel 10 ; Phelan, Bethany 2 ; Read, Nikki 2 ; Rodgers, Anthony 11 ; Schmaal, Lianne 2 ; Somogyi, Andrew A. 12 ; Thurston, Lily 2 ; Weller, Amber 13 ; Davey, Christopher G. 1 

1  University of Melbourne, Department of Psychiatry, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X); Orygen, Melbourne, Australia (GRID:grid.488501.0); University of Melbourne, Centre for Youth Mental Health, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X) 
2  Orygen, Melbourne, Australia (GRID:grid.488501.0); University of Melbourne, Centre for Youth Mental Health, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X) 
3  University of Melbourne, Department of Psychiatry, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X); University of Münster, Department of Psychiatry, Münster, Germany (GRID:grid.5949.1) (ISNI:0000 0001 2172 9288); The Florey Institute of Neuroscience and Mental Health, Melbourne, Australia (GRID:grid.418025.a) (ISNI:0000 0004 0606 5526) 
4  Orygen, Melbourne, Australia (GRID:grid.488501.0); Deakin University, IMPACT, The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia (GRID:grid.1021.2) (ISNI:0000 0001 0526 7079) 
5  The University of Sydney, Central Clinical School, Faculty of Medicine and Health, Sydney, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X); Australian Research Council Centre of Excellence for Children and Families Over the Life Course, Sydney, Australia (GRID:grid.1013.3); Royal Prince Alfred Hospital, Professor Marie Bashir Centre, Sydney, Australia (GRID:grid.413249.9) (ISNI:0000 0004 0385 0051) 
6  University of Melbourne, Department of Psychiatry, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X) 
7  Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia (GRID:grid.1034.6) (ISNI:0000 0001 1555 3415) 
8  Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia (GRID:grid.1034.6) (ISNI:0000 0001 1555 3415); Thompson Brain and Mind Healthcare, Sunshine Coast, Australia (GRID:grid.1034.6) 
9  University of New South Wales, School of Psychiatry, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432); Black Dog Institute, Sydney, Australia (GRID:grid.418393.4) (ISNI:0000 0001 0640 7766) 
10  Black Dog Institute, Sydney, Australia (GRID:grid.418393.4) (ISNI:0000 0001 0640 7766); University of New South Wales, School of Clinical Medicine, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432) 
11  The George Institute for Global Health, University of New South Wales, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432) 
12  University of Adelaide, School of Biomedicine, Adelaide, Australia (GRID:grid.1010.0) (ISNI:0000 0004 1936 7304) 
13  Orygen, Melbourne, Australia (GRID:grid.488501.0); University of Melbourne, Centre for Youth Mental Health, Melbourne, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X); Victorian Department of Health, Melbourne, Australia (GRID:grid.1008.9) 
Pages
686
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07631-3
ProQuest document ID
2881057131
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.