This double-masked, active placebo-controlled, single-dose randomised trial (n=80) will investigate the effects of intravenous (IV) ketamine versus remimazolam for depression in Veterans with Parkinson’s disease (PD).
Led by the VA Office of Research and Development, this study aims to determine if ketamine can alleviate depressive symptoms within 24 hours, and assess its impact on neuroplasticity and inflammation in PD patients.
Participants, aged between 40 to 80 years, must have neurologist-diagnosed idiopathic PD for at least six months, and a history of inadequate response to at least one trial of antidepressant medication. They should be on a stable regimen of all medications for at least two months prior to enrollment.
The primary outcome measure is the Montgomery-Asberg Depression Rating Scale (MADRS), assessing changes in depression severity within 24 hours post-infusion. Secondary measures include various scales for depression, anxiety, quality of life, and adverse events.
The study is expected to start on July 1, 2024, with a primary completion date set for June 30, 2029.
Trial Details
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