Imaging Depression in Parkinson's Disease
Recruiting · NCT06402955 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
11C-UCB-Jketamine hydrochloride
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 be excluded.
Exclusion criteria
- 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 risk and/or might affect the study objectives, as determined by study physicians.
- 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 patients who have hypertension.
- 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.
Where it is running
1 location listed across 1 US state.
- Yale University - New Haven, Connecticut, United States