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
Plain-Language Summary
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.