This randomised, double-blind, placebo-controlled trial (n=56) will investigate the efficacy and safety of repeated ketamine infusions compared to a placebo in individuals with Parkinson’s disease (PD) who also have major depressive disorder (MDD).
Conducted by Yale University, participants aged 40-80 with PD stages 1-3 and diagnosed with MDD will undergo either ketamine or placebo infusions. The study aims to determine whether ketamine treatment reduces depression severity compared to a placebo. Additionally, a subset of participants will undergo PET and fMRI scans to examine synaptic density and functional network reorganization associated with ketamine’s antidepressant effects in PD.
The primary outcome measure is the change in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary measures include changes in blood pressure, heart rate, respiration, O2 saturation, ECG, CBC with differential, complete metabolic panel, thyroid function tests, and routine urinalysis. Adverse events will also be assessed.
Collaborators include the Fox Foundation for Parkinson’s Research, and the study is led by Sophie E. Holmes, PhD. Recruitment started on November 23, 2021, and the estimated completion date is August 2024.
Trial Details
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Sponsors & Collaborators
Yale UniversityThe Yale Psychedelic Science Group was established in 2016.