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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 disorder950.05 kB
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Preprint
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
Research Square, Vol.8 September 2023
Research Square Company
2023
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 to 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 four weeks. The primary outcome is change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) after four 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 Schwartz (Corresponding Author) - The University of MelbourneG Paul Amminger (Author) - OrygenBernard T Baune (Author) - University of MünsterGillinder Bedi (Author) - OrygenMichael Berk (Author) - Deakin UniversitySue M. Cotton (Author) - OrygenRothanthi Daglas-Georgiou (Author) - OrygenNick Glozier (Author) - The University of SydneyBen J Harrison (Author) - The University of MelbourneDaniel Hermens (Author) - University of the Sunshine Coast, Queensland, Thompson InstituteEmma Jennings (Author) - OrygenJim Lagopoulos (Author) - University of the Sunshine Coast, Queensland, Thompson InstituteColleen Loo (Author) - UNSW SydneySumudu Mallawaarachchi (Author) - OrygenDonel M Martin (Author) - UNSW SydneyBethany Phelan (Author) - OrygenNikki Read (Author) - OrygenAnthony Rodgers (Author) - University of MünsterLianne Schmaal (Author) - The University of MelbourneAndrew A. Somogyi (Author) - The University of AdelaideLily Thurston (Author) - OrygenAmber Weller (Author) - Department of Health and Human ServicesChristopher G Davey (Author) - The University of Melbourne
- Publication details
- Research Square, Vol.8 September 2023
- Publisher
- Research Square Company
- Date published
- 2023
- DOI
- 10.21203/rs.3.rs-3158995/v1
- ISSN
- 2693-5015
- Copyright note
- This work is licensed under a Creative Commons Attribution 4.0 International License.
- Organisation Unit
- University of the Sunshine Coast, Queensland; Thompson Institute
- Language
- English
- Record Identifier
- 99966897402621
- Output Type
- Preprint
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