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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 will study whether ketamine can help treat depression in people with Parkinson's disease, and will also do brain scans to see how ketamine may be working.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Depression Severity
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,874 Previous Clinical Trials
2,953,500 Total Patients Enrolled
Fox (Michael J.) Foundation for Parkinson's ResearchUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
Sophie E. Holmes, PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Ketamine Infusion (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04944017 — Phase 2
Parkinson's Disease Research Study Groups: Ketamine Infusion, Saline Infusion
Parkinson's Disease Clinical Trial 2023: Ketamine Infusion Highlights & Side Effects. Trial Name: NCT04944017 — Phase 2
Ketamine Infusion (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04944017 — Phase 2
~0 spots leftby Aug 2024