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New treatment option for Parkinson's Disease
Official title Imaging Depression in Parkinson's Disease
ClinicalTrials.gov ID: NCT06402955
What this study is testing
What is ketamine hydrochloride?
ketamine hydrochloride is an investigational medicine, being studied as a potential treatment for parkinson's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this observational study is to identify targetable neural substrates of depression in Parkinson's Disease for the first time in people with Parkinson's between the ages of 40 and 80, who are experiencing symptoms of depression.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Age 40-80.
- For women of reproductive potential, a negative pregnancy test at screening and scanning
- For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures
- For PD depression patients - at least moderate symptom severity as determined by at least 15 on the MADRS, which has shown maximum discrimination...
- For dPD patients undergoing ketamine, abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the...
You likely can't join if
- Dementia (Montreal Cognitive Assessment (MoCA) score \<21)
- A significant primary DSM-5 psychiatric disorder except for MDD
- A history of or current significant medical (e.g. cardiovascular, renal), or neurological (e.g. cerebrovascular, seizure, traumatic brain injury)...
- Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation...
- Medications affecting SV2A availability (e.g. levetiracetam)
- For dPD patients receiving ketamine, uncontrolled hypertension, defined as average blood pressure greater than or equal to 140 mmHg or an average...
See the full eligibility criteria
- Age 40-80.
- For women of reproductive potential, a negative pregnancy test at screening and scanning
- For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures
- For PD depression patients - at least moderate symptom severity as determined by at least 15 on the MADRS, which has shown maximum discrimination between depressed and non-depressed PD patients.
- For dPD patients undergoing ketamine, abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the study. Patients with substance use disorders as defined by the DSM-5 will...
- Dementia (Montreal Cognitive Assessment (MoCA) score \<21)
- A significant primary DSM-5 psychiatric disorder except for MDD
- 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...
- Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation exposure
- Medications affecting SV2A availability (e.g. levetiracetam)
- For dPD patients receiving ketamine, 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...
- Contraindications to MRI.
- For patients undergoing arterial sampling for the PET scan: Iodine allergy, bleeding disorder and/or use of blood thinning medication
- Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.