NCT06402955RecruitingPhase 2
Imaging Depression in Parkinson's Disease
Identifying the Neural Basis of Depression in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 2 May 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Yale University
- Diseases
- Depression, Parkinson disease
- NCT number
- NCT06402955
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 1 Sept 2024 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- For patients undergoing arterial sampling for the PET scan: Iodine allergy, bleeding disorder and/or use of blood thinning medication
Other
- Contraindications to MRI.
- Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.