Imaging Depression in Parkinson's Disease

Launched by YALE UNIVERSITY · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Imaging Depression in Parkinson's Disease," is focused on understanding how depression affects people with Parkinson's Disease (PD). The study aims to identify specific areas in the brain that may be linked to depression in individuals aged 40 to 80 who have been diagnosed with PD and are experiencing moderate to severe symptoms of depression. By using advanced imaging techniques, researchers hope to uncover new insights that could lead to better treatment options for these patients.

To participate in the study, individuals should be between 40 and 80 years old, generally healthy, and have a clinical diagnosis of Parkinson's Disease along with signs of depression. Participants will undergo imaging tests, which are safe and non-invasive, and will be carefully monitored throughout the trial. It’s important to note that certain conditions, such as severe dementia or other significant medical issues, may exclude someone from joining. If you or a loved one meets the eligibility criteria and is interested in contributing to this important research, please consider reaching out for more information.

Gender

ALL

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 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.