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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 4 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.