No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for people aged 40 to 80 with Parkinson's Disease who are experiencing symptoms of depression. Participants will undergo imaging procedures to help understand depression in Parkinson's patients.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 40 and 80 years old.
I have been diagnosed with Parkinson's Disease.
I can give my consent for the study.
I have moderate to severe depressive symptoms.
I can tolerate PET procedures.
I am a woman and have had a negative pregnancy test.
I have not used illegal drugs during the study.
I have not used substances that affect my health or the study results.
You may not be able to join if
I have dementia.
I have a significant psychiatric disorder other than depression.
I have a serious medical condition that could affect my participation.
I have had too much radiation exposure for research in the past.
I take medications that affect SV2A availability.
I have uncontrolled high blood pressure.
I cannot have an MRI.
I cannot provide written consent in English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 40-80.
2. For women of reproductive potential, a negative pregnancy test at screening and scanning
3. For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures
4. For PD depression patients - at least moderate symptom severity as determined by…
Inclusion Criteria:
1. Age 40-80.
2. For women of reproductive potential, a negative pregnancy test at screening and scanning
3. For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures
4. 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.
5. 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 be excluded.
Exclusion Criteria:
1. Dementia (Montreal Cognitive Assessment (MoCA) score \<21)
2. A significant primary DSM-5 psychiatric disorder except for MDD
3. 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 risk and/or might affect the study objectives, as determined by study physicians.
4. Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation exposure
5. Medications affecting SV2A availability (e.g. levetiracetam)
6. 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 patients who have hypertension.
7. Contraindications to MRI.
8. For patients undergoing arterial sampling for the PET scan: Iodine allergy, bleeding disorder and/or use of blood thinning medication
9. Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.
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