NCT06143293

Who might be able to join this trial:

For people with depression who already have a VNS (nerve stimulator) device implanted (Group 1a):

• You must be at least 18 years old.
• You must be able to understand and sign a consent form agreeing to take part.
• You must have active health insurance that covers standard medical care and any injuries related to the study.
• You must have had a VNS (vagus nerve stimulator) device previously implanted specifically to treat major depression.
• You must be willing and able to attend all study visits and complete all required assessments.
• Any medications you are taking must have been stable for at least 2 months before joining, and you must be willing to keep them the same through your second study visit.
• If you are able to become pregnant, you must be willing to use an acceptable form of birth control for the entire study (this includes abstinence, barrier methods, hormonal methods, sterilization, or fertility awareness).

For people with depression who would receive a new VNS device as part of the study (Group 1b):

• You must be at least 18 years old.
• You must be able to understand and sign a consent form agreeing to take part.
• You must have active health insurance that covers standard medical care and any injuries related to the study.
• You must have been diagnosed with long-term depression lasting 2 or more years, or have had 4 or more separate episodes of depression, and your doctors must consider a VNS device medically appropriate for you.
• You must not have responded well enough to at least 4 adequate antidepressant treatments from at least 2 different types of antidepressants during your current episode of depression.
• You must score 22 or higher on a standard depression rating scale used at the start of the study (confirm with trial site).
• You must be willing and able to attend all study visits and complete all required assessments.
• Any medications you are taking must have been stable for at least 2 months before joining, and you must be willing to keep them the same through your second study visit.
• If you are able to become pregnant, you must be willing to use an acceptable form of birth control for the entire study (this includes abstinence, barrier methods, hormonal methods, sterilization, or fertility awareness).

For people with epilepsy that hasn't responded to medications who already have a VNS device implanted (Group 2a):

• You must be at least 18 years old.
• You must be able to understand and sign a consent form agreeing to take part.
• You must have active health insurance that covers standard medical care and any injuries related to the study.
• You must have had a VNS device previously implanted specifically to treat drug-resistant epilepsy.
• Your implanted VNS device must not have clearly helped with your seizures, their severity, or related issues such as mood, thinking, or quality of life.
• Apart from your epilepsy, your general health must be stable.
• You must be willing and able to attend all study visits and complete all required assessments.
• Any medications you are taking must have been stable for at least 2 months before joining, and you must be willing to keep them the same through your second study visit.
• If you are able to become pregnant, you must be willing to use an acceptable form of birth control for the entire study (this includes abstinence, barrier methods, hormonal methods, sterilization, or fertility awareness).

For people with epilepsy that hasn't responded to medications who would receive a new VNS device as part of the study (Group 2b):

• You must be at least 18 years old.
• You must be able to understand and sign a consent form agreeing to take part.
• You must have active health insurance that covers standard medical care, injuries, and the cost of the VNS implant surgery.
• You must have been diagnosed with drug-resistant epilepsy, meaning your seizures have continued despite trying at least 2 appropriate anti-seizure medications at the right doses.
• Apart from your epilepsy, your general health must be stable.
• You must be willing and able to attend all study visits and complete all required assessments.
• Any medications you are taking must have been stable for at least 2 months before joining, and you must be willing to keep them the same through your second study visit.