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
Plain-Language Summary
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.