Imaging Depression in Parkinson's Disease

Major Depressive Disorder Clinical Trial

Official title:

Identifying the Neural Basis of Depression in Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402955
• Other study ID #: 2000037090
• Secondary ID: R01NS125482-01A1
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Sophie Holmes
• Phone: 2036854066
• Email: sophie.holmes[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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:

1. 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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Parkinson Disease
• Parkinson's Disease

Intervention

Radiation:
• 11C-UCB-J
Radiotracer for imaging.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Neurological Disorders and Stroke (NINDS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)	This assessment stratifies severity of depressive episodes in adults. Ratings are based on clinical interview with the patient. Use clinical judgment to determine whether the rating lies on the defined scale steps (0, 2, 4, 6 points) or between them (1, 3, 5 points, denoted as "(Worsening symptoms)").The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression," and a total score of 60 or greater indicates "very severe depression."	One day
Secondary	Binding potential (BPND)	Binding potential (BPND) reflects the ratio at equilibrium of specifically bound radioligand to that of non-displaceable radioligand in tissue. BPND maps will be generated using the simplified reference tissue method 2 (SRTM2) and the centrum semiovale (CS) as reference region.	One week