Ketamine for the Treatment of Depression in Parkinson’s Disease

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.

Topic Depression Neurocognitive Disorders
Compound Placebo Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 23 November 2021
End date 31 August 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 56
Sex All
Age 40- 79
Therapy No

Trial Details

The main purpose of this study is to examine the efficacy and safety of a repeated dosing ketamine infusion paradigm compared to placebo in individuals with PD. A subset of participants in each arm will undergo baseline and post-treatment PET and fMRI scans, to examine whether changes in synaptic density and reorganization of functional networks underlie ketamine's putative antidepressant effects in PD.

Trial Number NCT04944017

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

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