Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD)

  • STATUS
    Recruiting
  • End date
    Aug 17, 2024
  • participants needed
    56
  • sponsor
    Yale University
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Updated on 7 October 2022
See if I qualify
ketamine
depression
depressive disorder
depressed mood
hoehn and yahr scale

Summary

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.

Description

This study will assess the efficacy of ketamine for the treatment of depression in Parkinson's disease (PD), in a parallel, double-blind, placebo controlled randomized clinical trial (RCT). Imaging will be used to examine the mechanistic effects of ketamine treatment. Specifically, the investigators will use positron emission tomography (PET) to measure synaptic density and functional magnetic resonance imaging (fMRI) to measure functional connectivity. The investigators hypothesize that a course of ketamine treatment will result in a significant reduction in depression severity compared to placebo. Mechanistically, ketamine will result in a reorganization of functional networks and an increase in synaptic density.

Details
Condition Parkinson's Disease, Depression
Treatment Ketamine infusion, Placebo - Saline Infusion
Clinical Study IdentifierNCT04944017
SponsorYale University
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female ages 40-75 years, inclusive
Clinical diagnosis of Parkinson's disease, stage 1, 2 or 3 as determined by the Hoehn and Yahr Scale
Meet criteria for major depressive disorder (MDD) as determined by the Mini-International Neuropsychiatric Interview (MINI), and at least 15 on the MADRS, which has shown maximum discrimination between depressed and non-depressed PD patients
For women of reproductive potential, use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation, as well as a negative pregnancy test at screening
Abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the study
Stated willingness to comply with all study procedures and availability for the duration of the study
Provision of signed and dated informed consent form

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation
in this study
Presence of Dementia (Montreal Cognitive Assessment (MoCA) score < 21)
A primary psychiatric disorder (as determined by the MINI) except for MDD
Active suicidal ideation with intent
History of substance dependence in the last 2 years
Current substance use disorder, except tobacco use disorder
Prior clinical psychiatric treatment with ketamine or prior recreational use of
ketamine
A history of or current significant medical (e.g. cardiovascular, renal), or
neurological (e.g. cerebrovascular, seizure, traumatic brain injury) illness other
than PD that is unstable and significantly increase their risk and/or might affect the
study objectives, as determined by study physicians
Uncontrolled hypertension, defined as average blood pressure greater than or equal to
mmHg or an average diastolic blood pressure greater than or equal to 90 mmHg among
those patients who have hypertension
Orthostatic hypotension (OH) that presents with symptoms sustained longer than a few
minutes (e.g., light-headedness, blurred vision, dizziness, weakness, fatigue) or with
syncope. OH is defined by a decrease in systolic blood pressure of 20 mm Hg or a
decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing compared
Inability to provide written informed consent according to the Yale Human
with blood pressure from the sitting position
Investigation Committee (HIC) guidelines
Any condition or finding that in the judgement of the PI significantly increases risk
or significantly reduces the likelihood of benefit from participation in the study
For participation in the PET/fMRI only
Prior radiation exposure for research purposes within such that participation in this
study would place them over FDA limits for annual radiation exposure (5 rem per yr)
Contraindications to MRI scanning
Presence of a bleeding disorder as determined by the PT/INR (Prothrombin time and
international normalized ratio) test
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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hoehn and yahr scale

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