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

Trials

Study Protocol

Donel Martin¹  Nick Glozier²  Ben Harrison³  Bernard T. Baune⁴  Orli S. Schwartz⁵  Christopher G. Davey⁵  Sumudu Mallawaarachchi⁶  Lianne Schmaal⁶  Paul Amminger⁶  Bethany Phelan⁶  Nikki Read⁶  Gillinder Bedi⁶  Sue M. Cotton⁶  Emma Jennings⁶  Rothanthi Daglas-Georgiou⁶  Lily Thurston⁶  Amber Weller⁷  Michael Berk⁸  Andrew A. Somogyi⁹  Colleen Loo^1,10  Anthony Rodgers^1,11  Daniel F. Hermens^1,12  Jim Lagopoulos^1,13 

[1] Black Dog Institute, Sydney, Australia;School of Clinical Medicine, University of New South Wales, Sydney, Australia;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;Department of Psychiatry, University of Melbourne, Melbourne, Australia;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;Department of Psychiatry, University of Melbourne, Melbourne, Australia;Orygen, Melbourne, Australia;Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia;Orygen, Melbourne, Australia;Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia;Orygen, Melbourne, Australia;Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia;Victorian Department of Health, Melbourne, Australia;Orygen, Melbourne, Australia;Deakin University, IMPACT, The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia;School of Biomedicine, University of Adelaide, Adelaide, Australia;School of Psychiatry, University of New South Wales, Sydney, Australia;Black Dog Institute, Sydney, Australia;The George Institute for Global Health, University of New South Wales, Sydney, Australia;Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia;Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia;Thompson Brain and Mind Healthcare, Sunshine Coast, Australia;

关键词: Ketamine;    Depression;    Major depressive disorder;    Young people;    Youth;    Adolescence;    Mental Health;    Psychiatry;   

DOI  :  10.1186/s13063-023-07631-3

 received in 2023-07-11, accepted in 2023-09-07,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundExisting 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).MethodsSKY-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.DiscussionResults 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 registrationAustralian and New Zealand Clinical Trials Registry ID: ACTRN12619000683134. Registered on May 7, 2019. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377513.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023