Phase 2 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand the study and sign a written consent form
• People who are United States Veterans
• People who are between 40 and 80 years old at the time of joining the study
• People who have been diagnosed with Parkinson's disease by a neurologist for at least six months before enrolling
• People who have tried at least one antidepressant medication in the past and did not respond well enough to it
• People who have been on the same medications for at least two months before enrolling, with no planned medication changes during the study
• People who are able to attend all required in-person and remote study visits and complete all data collection
• People whose depression symptoms score at a moderate or higher level on a standard rating scale (called the MADRS) at the start of the study
• People already in therapy or other non-drug depression treatments who agree to keep that consistent throughout the study
• People not currently in therapy or other non-drug depression treatments who agree not to start any new such treatment during the study
• People who agree to avoid cannabis for at least 72 hours before certain assessment days and to remain cannabis-free through those assessments
• People who regularly use tobacco or nicotine and agree to keep their use consistent throughout the study; or people who use tobacco or nicotine only occasionally and agree to stop entirely during the study
• People who are able to become pregnant or who are trying to conceive, and who agree to use highly effective contraception from the time of joining through the Day 7 assessments

Who may not be able to join:

• People with a lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, or who currently have psychosis with loss of insight
• People with dementia or significant memory and thinking difficulties, as measured by a standard screening test (confirm with trial site)
• People with a moderate or severe substance use disorder in the six months before enrolling, or who show any alcohol in their system at screening, or who test positive for certain substances at screening (a positive cannabis result is handled separately — see inclusion criteria above)
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who have had electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days before enrolling, or who plan to start either during the study
• People who are assessed as being at high risk of self-harm or suicide requiring immediate care, based on a standard safety scale used at screening
• People whose depression is so severe at screening that they are unable to take care of their own basic needs or safety, and who need immediate treatment
• People with certain safety concerns related to TMS, including a history of seizures, metal or implanted devices above the chest, a history of severe traumatic brain injury, or tinnitus (ringing in the ears)
• People with certain safety concerns related to ketamine, including a previous allergic reaction to ketamine, hepatitis or liver failure, bladder inflammation (cystitis), or heart or blood vessel conditions where a rise in blood pressure could cause complications
• People taking certain medications that could interfere with ketamine treatment or raise the risk of side effects (such as benzodiazepines, sleeping medications, lamotrigine, or MAOIs), unless it is medically appropriate and possible to stop those medications for a set period around the assessment days (confirm with trial site)
• People taking certain medications that may affect brain activity related to the study (such as memantine or dextromethorphan), unless it is medically appropriate and possible to stop those medications for a set period around the assessment days (confirm with trial site)
• People taking certain medications that may increase the risk of seizures with TMS, unless it is medically appropriate and possible to stop those medications for a set period around the assessment days (confirm with trial site)
• People with autoimmune conditions (such as multiple sclerosis, lupus, or rheumatoid arthritis) or cancer-related conditions
• People taking medications that affect the immune system or inflammation, unless their dose has been stable for at least two months and there are no plans to change it during the study
• People with any other medical condition, test result, or physical finding that the trial team determines makes participation unsafe

Important: Always verify eligibility with the trial site directly before applying.