Imaging Depression in Parkinson's Disease
Purpose
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.
Conditions
- Parkinson's Disease
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Age 40-80. 2. Physically healthy by medical history, physical, ECG and laboratory examinations 3. For women of reproductive potential, a negative pregnancy test at screening and scanning 4. For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures 5. For PD depression patients - at least moderate symptom severity as determined by a cut-off of 14 on the HAMD-17, which has shown maximum discrimination between depressed and non-depressed PD patients87.
Exclusion Criteria
- Dementia (Montreal Cognitive Assessment (MoCA) score <21)88 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, blood pressure >145/90. 7. Contraindications to MRI. 8. Iodine allergy 9. Bleeding disorder or thinning blood medication 10. Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Parkinson's Disease | This group will consist of people who have been diagnosed with Parkinson's Disease, but not Major Depressive Disorder. |
|
| Parkinson's Disease with Major Depressive Disorder | This is the main group that the other three groups will be compared to. This study aims to identify mechanisms unique to patients with both Parkinson's Disease and Major Depressive Disorder. |
|
| Major Depressive Disorder | This group will consist of people who have been diagnosed with Major Depressive Disorder, but not Parkinson's Disease. |
|
| Healthy Controls | This group will consist of people that do not have Parkinson's Disease or Major Depressive Disorder. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Yale University
Detailed Description
This study will compare people with Parkinson's Disease and depression to individuals with Parkinson's Disease without Major Depressive Disorder, Major Depressive Disorder with no Parkinson's, and Healthy Controls. Up to 30 participants will be recruited and enrolled for each of these 4 groups. Participants will be asked to complete one PET and one MRI scan along with study assessments. Once screening and consent is completed, participants will be scheduled for PET and MRI scans. The total duration for participants in this study is 7 hours, including the screening visit and then one additional visit for the scans. The main questions it aims to answer are: 1) Will the Parkinson's depression group exhibit a distinct pattern of synaptic deficits compared to other groups? 2) Will there be differences in functional connectivity across groups? 3) Are there associations between synaptic density and functional connectivity across groups?
