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

Orli S. Schwartz; Paul Amminger; Bernard T. Baune; Gillinder Bedi; Michael Berk; Sue M. Cotton; Rothanthi Daglas-Georgiou; Nick Glozier; Ben Harrison; Daniel F. Hermens; Emma Jennings; Jim Lagopoulos; Colleen Loo; Sumudu Mallawaarachchi; Donel Martin; Bethany Phelan; Nikki Read; Anthony Rodgers; Lianne Schmaal; Andrew A. Somogyi; Lily Thurston; Amber Weller; Christopher G. Davey

doi:10.1186/s13063-023-07631-3

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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

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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

Orli S. Schwartz, Paul Amminger, Bernard T. Baune, Gillinder Bedi, Michael Berk, Sue M. Cotton, Rothanthi Daglas-Georgiou, Nick Glozier, Ben Harrison, Daniel F. Hermens, …

Trials, Vol.24, pp.1-19

2023

DOI: https://doi.org/10.1186/s13063-023-07631-3

PMCID: PMC10594918

PMID: 37875938

Appears in Thompson Institute Research Collection

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Abstract

ketamine

depression

major depressive disorder

young people

youth

adolescence

mental health

psychiatry

Ketamine

Thompson Institute Special Collection

UniSC Diversity Area - Disability and Inclusion

UniSC Diversity Area - Life Stages

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
Authors: Orli S. Schwartz (Corresponding Author) - The University of Melbourne
Paul Amminger (Author) - The University of Melbourne
Bernard T. Baune (Author) - University of Münster
Gillinder Bedi (Author) - Orygen
Michael Berk (Author) - Deakin University
Sue M. Cotton (Author) - Orygen
Rothanthi Daglas-Georgiou (Author) - The University of Melbourne
Nick Glozier (Author) - The University of Sydney
Ben Harrison (Author) - The University of Melbourne
Daniel F. Hermens (Author) - University of the Sunshine Coast, Queensland, Thompson Institute
Emma Jennings (Author) - Orygen
Jim Lagopoulos (Author) - University of the Sunshine Coast, Queensland, Thompson Institute
Colleen Loo (Author) - UNSW Sydney
Sumudu Mallawaarachchi (Author) - Orygen
Donel Martin (Author) - Black Dog Institute
Bethany Phelan (Author) - Orygen
Nikki Read (Author) - Orygen
Anthony Rodgers (Author) - The George Institute for Global Health
Lianne Schmaal (Author) - The University of Melbourne
Andrew A. Somogyi (Author) - The University of Adelaide
Lily Thurston (Author) - Orygen
Amber Weller (Author) - Orygen
Christopher G. Davey (Author) - The University of Melbourne
Publication details: Trials, Vol.24, pp.1-19
Publisher: BioMed Central Ltd.
Date published: 2023
DOI: 10.1186/s13063-023-07631-3
ISSN: 1745-6215
PMID: 37875938; PMC10594918
Copyright note: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Grant note: This study is funded by National Health and Medical Research Council Project Grant APP1138736 and Orygen. The study is sponsored by Orygen. The study funders and sponsor had no role in the design of the study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. MB is supported by a NHMRC Senior Principal Research Fellowship and Leadership 3 Investigator grant (1156072 and 2017131).
Organisation Unit: Thompson Institute
Language: English
Record Identifier: 99971751002621
Output Type: Journal article

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