New Haven,
Connecticut
06510
Purpose:
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.
Study summary:
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).
Criteria:
Inclusion Criteria:
1. Male or female ages 40-75 years, inclusive
2. Clinical diagnosis of Parkinson's disease, stage 1, 2 or 3 as determined by the Hoehn
and Yahr Scale
3. 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.
4. 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.
5. Abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine
for the duration of the study.
6. Stated willingness to comply with all study procedures and availability for the
duration of the study.
7. 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:
1. Presence of Dementia (Montreal Cognitive Assessment (MoCA) score < 21)
2. A primary psychiatric disorder (as determined by the MINI) except for MDD
3. Active suicidal ideation with intent
4. History of substance dependence in the last 2 years
5. Current substance use disorder, except tobacco use disorder
6. Prior clinical psychiatric treatment with ketamine or prior recreational use of
ketamine
7. 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
8. Uncontrolled hypertension, defined as average blood pressure greater than or equal to
140 mmHg or an average diastolic blood pressure greater than or equal to 90 mmHg among
those patients who have hypertension.
9. 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
with blood pressure from the sitting position.
10. Inability to provide written informed consent according to the Yale Human
Investigation Committee (HIC) guidelines.
11. 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.