11C-UCB-J for Parkinson's (NCT06402955)
Treat Parkinsons depression with ketamine
- Trial ID
- NCT06402955
- Official Title
- Identifying the Neural Basis of Depression in Parkinson's Disease
- Goal
- Treat Parkinsons depression with ketamine
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Yale University
- Study Type
- INTERVENTIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson's Disease, Major Depressive Disorder
- Interventions
- 11C-UCB-J, ketamine hydrochloride
Summary For Families
They want to pin down the brain changes that underlie depression in Parkinson's, by measuring synaptic differences between people with and without depression and seeing how those patterns change after an antidepressant. Participants get PET scans with 11C-UCB-J, a tracer that binds the synaptic protein SV2A to estimate synaptic density, and people with depressed Parkinson's will receive a ketamine infusion, which blocks NMDA receptors and triggers a rapid glutamate-driven burst of synapse formation that can lift mood; ketamine is not a dopamine drug and does not replace levodopa. The trial enrolls adults 40 to 80 with Parkinson's, the depressed arm requires at least moderate symptoms (MADRS ≥15), and it excludes people with dementia (MoCA <21), other major psychiatric or unstable medical conditions, medications that affect SV2A such as levetiracetam, uncontrolled hypertension for ketamine recipients, or MRI/PET contraindications. Participants receiving ketamine must avoid drugs of abuse during the study and be able to give informed consent in English.
Locations
- Yale University, New Haven, Connecticut, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying 11C-UCB-J. They want to pin down the brain changes that underlie depression in Parkinson's, by measuring synaptic differences between people with and without depression and seeing how those patterns change after an antidepressant. Participants get PET scans with 11C-UCB-J, a tracer that binds the synaptic protein SV2A to estimate synaptic density, and people with depressed Parkinson's will receive a ketamine infusion, which blocks NMDA receptors and triggers a rapid glutamate-driven burst of synapse formation that can lift mood; ketamine is not a dopamine drug and does not replace levodopa. The trial enrolls adults 40 to 80 with Parkinson's, the depressed arm requires at least moderate symptoms (MADRS ≥15), and it excludes people with dementia (MoCA <21), other major psychiatric or unstable medical conditions, medications that affect SV2A such as levetiracetam, uncontrolled hypertension for ketamine recipients, or MRI/PET contraindications. Participants receiving ketamine must avoid drugs of abuse during the study and be able to give informed consent in English.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- A screening visit plus one additional visit for the scans, totaling 7 hours.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive). Confirm the full schedule with the study coordinator.