1. 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
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Schwartz, OS, Amminger, P, Baune, BT, Bedi, G, Berk, M, Cotton, SM, Daglas-Georgiou, R, Glozier, N, Harrison, B, Hermens, DF, Jennings, E, Lagopoulos, J, Loo, C, Mallawaarachchi, S, Martin, D, Phelan, B, Read, N, Rodgers, A, Schmaal, L, Somogyi, AA, Thurston, L, Weller, A, Davey, CG, Schwartz, OS, Amminger, P, Baune, BT, Bedi, G, Berk, M, Cotton, SM, Daglas-Georgiou, R, Glozier, N, Harrison, B, Hermens, DF, Jennings, E, Lagopoulos, J, Loo, C, Mallawaarachchi, S, Martin, D, Phelan, B, Read, N, Rodgers, A, Schmaal, L, Somogyi, AA, Thurston, L, Weller, A, and Davey, CG
- 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 .
- Published
- 2023