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.
- Resource Type
- Article
- Authors
- Schwartz, Orli S.; Amminger, Paul; Baune, Bernard T.; Bedi, Gillinder; Berk, Michael; Cotton, Sue M.; Daglas-Georgiou, Rothanthi; Glozier, Nick; Harrison, Ben; Hermens, Daniel F.; Jennings, Emma; Lagopoulos, Jim; Loo, Colleen; Mallawaarachchi, Sumudu; Martin, Donel; Phelan, Bethany; Read, Nikki; Rodgers, Anthony; Schmaal, Lianne; Somogyi, Andrew A.
- Source
- Trials. 10/24/2023, Vol. 24 Issue 1, p1-19. 19p. 4 Charts.
- Subject
- *KETAMINE
*YOUNG adults
*MENTAL depression
*RANDOMIZED controlled trials
*RESEARCH protocols
*SUBCUTANEOUS injections
- Language
- ISSN
- 1745-6215
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. [ABSTRACT FROM AUTHOR]