Ketamine treatment for depression in Parkinson's disease
Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD)
PHASE2 · Yale University · NCT04944017
This study is testing if ketamine infusions can help people with Parkinson's disease who also have depression feel better compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04944017 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of repeated ketamine infusions compared to a placebo in individuals with Parkinson's disease who also suffer from depression. It employs a double-blind, placebo-controlled randomized clinical trial design, where participants will receive either ketamine or saline infusions. Additionally, imaging techniques such as PET and fMRI will be utilized to explore the underlying mechanisms of ketamine's antidepressant effects, focusing on changes in synaptic density and functional connectivity. The hypothesis is that ketamine treatment will significantly reduce depression severity in this patient population.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40-80 with a clinical diagnosis of Parkinson's disease and major depressive disorder.
Not a fit: Patients with severe comorbid psychiatric disorders or those who do not meet the criteria for major depressive disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for managing depression in patients with Parkinson's disease.
How similar studies have performed: Other studies have shown promising results with ketamine for depression, particularly in treatment-resistant cases, suggesting potential success for this approach in Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Male or female ages 40-80 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 and a Montreal Cognitive Assessment (MoCA) score of less than 18.
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.
For participation in the PET/fMRI only:
12. 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)
13. Contraindications to MRI scanning.
14. Presence of a bleeding disorder as determined by the PT/INR (Prothrombin time and international normalized ratio) test
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Sophie E. Holmes, PhD — Yale University
- Study coordinator: Sophie E. Holmes, PhD
- Email: sophie.holmes@yale.edu
- Phone: 203-685-4066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease, Depression, Ketamine Treatment