NCT06402955 Imaging Depression in Parkinson's Disease
| NCT ID | NCT06402955 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yale University |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-09-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06402955 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06402955 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06402955 currently recruiting?
Yes, NCT06402955 is actively recruiting participants. Contact the research team at sophie.holmes@yale.edu for enrollment information.
Where is the NCT06402955 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06402955 clinical trial?
NCT06402955 is sponsored by Yale University. The trial plans to enroll 120 participants.
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