What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, dopamine agonists, MAO B inhibitors, and amantadine. Levodopa can lead to motor fluctuations and dyskinesias over time. Dopamine agonists are associated with side effects such as hallucinations, nausea, and dizziness. MAO B inhibitors generally have mild side effects but can include insomnia and headaches. Amantadine, which has NMDA receptor antagonist properties, can cause side effects like confusion, hallucinations, and livedo reticularis. NMDA receptor antagonists like ketamine, studied for their potential benefits in PD, may cause disorientation, dizziness, and increased blood pressure.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease include several drugs that target different pathways. While ketamine, an NMDA receptor antagonist, is being studied for its effects on synaptic density and functional network reorganization, other NMDA receptor antagonists like memantine have been explored for neuroprotective properties in neurodegenerative diseases. Additionally, amantadine, another NMDA receptor antagonist, is approved for treating motor symptoms in Parkinson's Disease. These treatments aim to manage symptoms and potentially offer neuroprotective benefits by modulating excitatory neurotransmission.

What other types of research exist?

Promising novel alternatives to ketamine for Parkinson's Disease patients include: <ol> <li>Cholinesterase Inhibitors (e.g., Rivastigmine, Donepezil) - These have shown mild to moderate benefits in cognitive function and neuropsychiatric symptoms in PD dementia.</li> <li>5-HT1A Receptor Stimulation combined with NMDA Receptor Antagonism - This combination has shown potential in reducing L-DOPA-induced dyskinesia and enhancing motor function.</li> <li></li> </ol> NR2B Antagonists (e.g., CP-101,606) - These have demonstrated improvements in levodopa-induced dyskinesia in preclinical models. 4. D3/D2 Receptor Agonists (e.g., S32504) - These have shown superior potency in restoring motor function and potential neuroprotective properties in preclinical studies.

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NMDA Receptor Antagonist

Ketamine for Depression in Parkinson's Disease (KET-PD Trial)

Phase 2

Recruiting

Led By Sophie E. Holmes, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Clinical diagnosis of Parkinson's disease, stage 1, 2 or 3 as determined by the Hoehn and Yahr Scale

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 2, and week 3

Awards & highlights

Summary

This trial is testing if ketamine can help reduce depression in people with Parkinson's disease. The study will use brain scans to see if ketamine changes brain activity and increases connections between brain cells. Researchers hope that these changes will lead to less severe depression symptoms. Ketamine has been studied for its potential effects on depression and other symptoms in Parkinson's disease.

Who is the study for?

This trial is for people aged 40-80 with Parkinson's Disease (stages 1-3) and major depression, who don't have dementia or other serious medical conditions. Participants must not use drugs of abuse, agree to contraception if applicable, and be willing to follow the study plan.

What is being tested?

The trial tests repeated doses of ketamine infusion against a saline placebo in those with Parkinson's Disease to see if it helps with depression. Some participants will also get brain scans before and after treatment to look at changes related to ketamine's effects.

What are the potential side effects?

Ketamine can cause side effects like disorientation, nausea, increased blood pressure, mood swings, blurred vision, dizziness or feeling detached from reality. Long-term safety in this context is part of what the study aims to find out.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major depression and scored at least 15 on a depression scale.

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I have Parkinson's disease at stage 1, 2, or 3.

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not controlled and is often 140/90 mmHg or higher.

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I experience significant dizziness or fainting when standing up.

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I have used ketamine before, either for medical reasons or recreationally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 2, and week 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 2, and week 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, and week 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Depression Severity

Secondary study objectives

Adverse events

Change in Blood pressure: diastolic

Change in Blood pressure: systolic

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ketamine InfusionExperimental Treatment1 Intervention

Participants will receive 6 infusions of ketamine (0.5 mg/kg IV, up to 60 mg total) , administered over 40 minutes while on continuous cardiac monitoring and oximetry

Group II: Saline InfusionPlacebo Group1 Intervention

Participants will receive 6 infusions of placebo (saline IV), administered over 40 minutes while on continuous cardiac monitoring and oximetry

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include levodopa, dopamine agonists, MAO-B inhibitors, and amantadine. Levodopa replenishes dopamine levels, dopamine agonists stimulate dopamine receptors, and MAO-B inhibitors prevent dopamine breakdown. Amantadine, an NMDA receptor antagonist, helps reduce tremor and dyskinesia. These treatments aim to restore dopamine function, crucial for motor control in PD patients. The study of ketamine, also an NMDA receptor antagonist, is significant as it explores synaptic density changes and functional network reorganization, potentially offering new insights into neuroplasticity and symptom management in PD.

What Happens When I Watch a Ballet and I Am Dyskinetic? A fMRI Case Report in Parkinson Disease.[The essence of essential tremor: neurochemical bases].Network modulation in the treatment of Parkinson's disease.