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NMDA Receptor Antagonist

Ketamine for Depression in Parkinson's Disease (KPD Trial)

Phase 2
Waitlist Available
Led By Ellen R Bradley, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 40-80 years old at the time of informed consent
Have a score >/=20 on the Montgomery-Asberg Depression Rating Scale (MADRS), consistent with moderate or greater depressive symptom severity, at Baseline
Must not have
Autoimmune disorders (e.g., multiple sclerosis, lupus, rheumatoid arthritis) or neoplastic disorders
Meeting standard safety exclusion criteria for ketamine treatment (previous hypersensitivity reaction to ketamine, hepatitis or liver failure, cystitis, or underlying cardiovascular conditions in which increased blood pressure would pose a risk of complications)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 hours post-infusion, 24 hours post-infusion, day 3, day 5, day 7

Summary

This trial is testing the use of ketamine as a potential treatment for depression in Veterans with Parkinson's disease (PD). Depression is a common and debilitating symptom in PD, but current treatments are not very

Who is the study for?
This trial is for Veterans with Parkinson's Disease who are experiencing depression. It aims to test if ketamine, known for its rapid antidepressant effects, can improve their condition and quality of life.
What is being tested?
The study is testing the effectiveness of intravenous (IV) ketamine compared to a placebo in treating depression in Veterans with Parkinson's Disease. It will also explore how ketamine may affect brain adaptability and inflammation.
What are the potential side effects?
Ketamine can cause side effects such as disorientation, elevated blood pressure, nausea, or hallucinations. The severity and occurrence vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 80 years old.
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My depression is moderate or severe, based on a specific test score.
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My medications have been the same for the last 2 months and won't change during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune or cancer-related disorder.
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I don't have allergies to ketamine, liver issues, bladder problems, or heart conditions that worsen with high blood pressure.
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I have never been diagnosed with schizophrenia, schizoaffective, or bipolar disorder, and I am not currently experiencing psychosis.
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I don't have seizures, metal implants above the chest, severe brain injuries, or severe tinnitus.
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I haven't had ECT or TMS in the last 30 days and don't plan to start during the trial.
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My depression is severe, affecting my ability to care for myself.
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I can stop taking certain medications that might affect the study before it starts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 hours post-infusion, 24 hours post-infusion, day 3, day 5, day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 hours post-infusion, 24 hours post-infusion, day 3, day 5, day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Changes in inflammatory index as measured by blood-based analysis
Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS- PD)
Frequency, Intensity, Burden of Side Effects Rating Scale (FIBSER)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetamineExperimental Treatment1 Intervention
intravenous ketamine infusion 0.5 mg/kg
Group II: RemimazolamPlacebo Group1 Intervention
intravenous remimazolam infusion 0.25 mg/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,691 Total Patients Enrolled
Ellen R Bradley, MDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
~53 spots leftby Jun 2029
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