期刊论文详细信息
Trials
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
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 Loo1,10  Anthony Rodgers1,11  Daniel F. Hermens1,12  Jim Lagopoulos1,13 
[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
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【 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

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【 参考文献 】
  • [1]
  • [2]
  • [3]
  • [4]
  • [5]
  • [6]
  • [7]
  • [8]
  • [9]
  • [10]
  • [11]
  • [12]
  • [13]
  • [14]
  • [15]
  • [16]
  • [17]
  • [18]
  • [19]
  • [20]
  • [21]
  • [22]
  • [23]
  • [24]
  • [25]
  • [26]
  • [27]
  • [28]
  • [29]
  • [30]
  • [31]
  • [32]
  • [33]
  • [34]
  • [35]
  • [36]
  • [37]
  • [38]
  • [39]
  • [40]
  • [41]
  • [42]
  • [43]
  • [44]
  • [45]
  • [46]
  • [47]
  • [48]
  • [49]
  • [50]
  • [51]
  • [52]
  • [53]
  • [54]
  • [55]
  • [56]
  • [57]
  • [58]
  • [59]
  • [60]
  • [61]
  • [62]
  • [63]
  • [64]
  • [65]
  • [66]
  • [67]
  • [68]
  • [69]
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