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?
- 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 3 years and 7 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.