Ketamine for Parkinson's (NCT06231563)
Reduce depressive symptoms using ketamine
- Trial ID
- NCT06231563
- Official Title
- Examining Ketamine Effects on Depression, Neuroplasticity, and Inflammation in Veterans With Parkinson's Disease
- Goal
- Reduce depressive symptoms using ketamine
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- INTERVENTIONAL
- Enrollment
- 80 participants
- Conditions
- Parkinson's Disease
- Interventions
- Ketamine, Remimazolam
Summary For Families
The team is testing whether ketamine can quickly ease moderate-to-severe depression in Veterans with Parkinson's, while also boosting brain plasticity and lowering inflammation that might hurt mood and brain health. Participants get ketamine infusions and are compared with remimazolam, an ultra-short-acting benzodiazepine used as a control; ketamine blocks NMDA receptors, triggers a glutamate surge and AMPA activation that helps form new synapses and produces rapid antidepressant effects, and the study will measure inflammatory markers and motor-cortex plasticity. Ketamine does not replace levodopa and the trial keeps people on stable Parkinson's meds, though benzodiazepines are limited because they can blunt ketamine's effects, and people with certain heart, liver, bladder, or psychiatric risks are excluded because ketamine can raise blood pressure and cause side effects. The study is enrolling U.S. Veterans age 40 to 80 with neurologist-diagnosed idiopathic PD for at least six months, a MADRS score of 20 or higher, and a history of inadequate response to at least one antidepressant, who can keep medications and treatments stable during participation.
Locations
- San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Ketamine. The team is testing whether ketamine can quickly ease moderate-to-severe depression in Veterans with Parkinson's, while also boosting brain plasticity and lowering inflammation that might hurt mood and brain health. Participants get ketamine infusions and are compared with remimazolam, an ultra-short-acting benzodiazepine used as a control; ketamine blocks NMDA receptors, triggers a glutamate surge and AMPA activation that helps form new synapses and produces rapid antidepressant effects, and the study will measure inflammatory markers and motor-cortex plasticity. Ketamine does not replace levodopa and the trial keeps people on stable Parkinson's meds, though benzodiazepines are limited because they can blunt ketamine's effects, and people with certain heart, liver, bladder, or psychiatric risks are excluded because ketamine can raise blood pressure and cause side effects. The study is enrolling U.S. Veterans age 40 to 80 with neurologist-diagnosed idiopathic PD for at least six months, a MADRS score of 20 or higher, and a history of inadequate response to at least one antidepressant, who can keep medications and treatments stable during participation.
- 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 3 years and 7 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?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Intravenous infusion (minimally invasive). Confirm the full schedule with the study coordinator.