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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 2, and week 3
Awards & highlights

KET-PD Trial 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.

KET-PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with major depression and scored at least 15 on a depression scale.
Select...
I have Parkinson's disease at stage 1, 2, or 3.
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I am between 40 and 80 years old.

KET-PD Trial 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

KET-PD 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

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,385 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this scientific investigation?

"Affirmative. The information posted on clinicaltrials.gov confirms that the research is actively seeking participants, with a recruitment window starting November 23 2021 and ending August 22 2022. The study seeks 56 volunteers from 1 medical centre."

Answered by AI

Does this research encompass members of the elderly population?

"According to the criteria, participants should be between 40 and 75 years old. Conversely, there are 229 trials available for youths below 18 and over 1,500 studies open to seniors above 65."

Answered by AI

Does the Federal Drug Administration endorse Ketamine Infusion?

"Although there is evidence of some safety benefits associated with Ketamine Infusion, the lack of efficacy data preclude a score higher than 2 on our scale."

Answered by AI

To whom is eligibility for participation in this research available?

"This research is recruiting 56 adults aged between 40 and 75 who have depression. To be considered, potential participants must satisfy the following requirements: Male or female age range of 40 to 75 years; Diagnosis of Parkinson's disease according to the Hoehn and Yahr Scale (level 1-3); Evidence of Major Depressive Disorder as established by Mini International Neuropsychiatric Interview (MINI) with a MADRS score above 15; For women capable of reproductive, contraception use for at least four weeks before screening plus agreement to maintain its application during trial period along with negative pregnancy test results; Refrainment from drugs other than alcohol, cannabis"

Answered by AI

Is this investigation actively seeking new participants?

"According to the data posted on clinicaltrials.gov, this research is still open for participants. It was initially advertised on November 23rd 2021 and had its most recent update August 22nd 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
Connecticut
How old are they?
65+
18 - 65
What site did they apply to?
Yale New Haven Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 1 Day
Most responsive sites:
  1. Yale New Haven Hospital: < 24 hours
~5 spots leftby Aug 2024