Ketamine for the Treatment of Depression in Parkinson's Disease

Recruiting
40 years - 70 years
All
Phase 2
56 participants needed

Study Overview

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 Details

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).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Parkinson's Disease, Depression
  • Age: 40 years - 70 years
  • Gender: All

Inclusion Criteria:

  1. Male or female ages 40-70 years, inclusive
  2. Clinical diagnosis of Parkinson's disease, stage 1 or 2 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. Physically healthy by medical history, physical, vital signs, ECG and laboratory examinations.
  5. 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.
  6. Abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the study.
  7. Stated willingness to comply with all study procedures and availability for the duration of the study.
  8. 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 significant psychiatric disorder (as determined by the MINI) except for MDD
          3. Active suicidal ideation with intent
          4. History of substance dependence
          5. Current substance use disorder, except tobacco use disorder
          6. Prior participation in a ketamine study, prior clinical psychiatric treatment with
             ketamine, or prior recreational use of ketamine
          7. A history of significant medical (e.g. cardiovascular, renal), or neurological (e.g.
             cerebrovascular, seizure, traumatic brain injury) illness other than PD that is
             unstable and/or might affect the study objectives
          8. History of 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 in English.

Updated on 12 Jan 2022. Study ID: NCT04944017

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