This open-label trial (n=24) investigates the efficacy of subcutaneous ketamine (21-42mg/70kg) for treating depression (MDD) in elderly patients.
In the first phase, participants with major depressive disorder (MDD) receive single doses of 0.3mg/kg and 0.6mg/kg ketamine in order, with a one-week gap. Phase 2 involves eligible patients from Phase 1 receiving 1-2x weekly ketamine dosing for up to 3 months based on their response.
The primary outcome is the change in depression rating scale (GDS: Geriatric Depression Scale) at 24 hours post-dose. Secondary outcomes include GDS scores in Phase 2.
The study, named KED (Ketamine Elderly Depression), is non-randomised, recruiting participants aged over 65. It aims to address the dearth of evidence-based guidelines for treating depression in elderly individuals, specifically MDDE, and evaluates the role of ketamine in achieving rapid anti-depressant effects.
The trial is registered on ANZCTR with registration number ACTRN12617001130358. It was submitted on 27/07/2017, registered on 2/08/2017, last updated on 17/07/2018, and has received ethics approval from the Southern Health and Disability Committee in New Zealand on 30/01/2018.
The study is still recruiting, with the anticipated dates for the first participant enrolment, last participant enrolment, and last data collection being 24/09/2018, 31/12/2019, and 30/04/2020, respectively.
The University of Otago is the primary sponsor, funding the research. Principal investigator A/Prof Yoram Barak is leading the study to evaluate ketamine’s effects on depression ratings, safety, and the potential for sustaining improvements in elderly patients with MDD.
Trial Details
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Sponsors & Collaborators
University of OtagoThe University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.