Depression and Anxiety 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:

• You are between 22 and 70 years old
• You have been diagnosed with Major Depressive Disorder (MDD) without psychosis, confirmed through a formal structured interview
• Your current episode of depression has lasted 2 years or longer and has not responded to treatment — specifically, you have tried at least 4 adequate treatments (including electroconvulsive therapy/ECT), at least 3 different types of medications, at least one add-on medication strategy, and psychotherapy
• You tried ECT but it either did not provide lasting relief (after 2 attempts to stop ECT it kept coming back) or you had to stop because the side effects were too difficult to tolerate
• Your depression symptoms score above 26 on a standard depression rating scale (called the MADRS) at both your screening and baseline appointments
• Your depression symptoms show some natural day-to-day variation, measured by a brief mood rating taken 3 times a day for 3 days (confirm with trial site)
• If you are already taking psychiatric medications, you have not changed them in the 4 weeks before joining and agree not to change them during the study
• You are willing and able to undergo a brain recording and stimulation procedure
• You are willing and able to come to multiple research visits and follow a research routine at home
• You are willing and able to give informed consent
• You can speak and read English

Who may not be able to join:

• You have been diagnosed with another major psychiatric condition such as a psychotic disorder, eating disorder, panic disorder, PTSD, bipolar disorder, OCD, a tic disorder, or another significant psychiatric disorder (note: generalized anxiety disorder alongside MDD may be acceptable — confirm with trial site)
• Your main diagnosis during your current depressive episode is generalized anxiety disorder rather than MDD
• You are currently having thoughts of suicide with a specific intent and plan
• You have been hospitalized for a suicide attempt in the past 2 years
• You have had problems with alcohol or substance misuse (other than caffeine) in the past 6 months
• You have a personality disorder that the study team believes could affect your safety or ability to follow the study requirements
• You have fibromyalgia or chronic fatigue syndrome
• You currently need to take narcotic (opioid) pain medications on an ongoing basis
• You have a history of traumatic brain injury, a neurological condition, or a developmental delay
• You have a history of seizures
• A recent brain MRI (within the past year) showed significant abnormalities
• You have previously had brain surgery to remove or destroy tissue, or you already have a deep brain stimulation device or another implanted brain stimulation device
• You have any implanted hardware in your body that is not compatible with MRI or with the study equipment
• You have serious medical conditions that would increase the risks of surgery — for example, severe diabetes, major organ failure, a history of bleeding stroke, need for blood-thinning medications (other than aspirin), active infection, a brain lesion, high pressure in the brain, a recent stroke, a brain aneurysm, retinal detachment, unstable heart disease, a weakened immune system, or cancer with a life expectancy of less than 5 years
• You are unable to safely stop blood-thinning or anti-clotting medications for surgery (your doctors would need to discuss this carefully — confirm with trial site)
• You have a blood clotting disorder, unless reviewed and cleared by a blood specialist
• You have allergies or known reactions to materials used in the NeuroPace RNS® device, such as titanium, silicone, or stainless steel
• You live alone with no one available to support you after your hospital stay
• You are unable to attend the required follow-up visits
• You are pregnant, planning to become pregnant, or currently breastfeeding
• You are unable to speak or read English
• You are unable to give informed consent
• You have significant memory or thinking difficulties or dementia (based on a standard cognitive test score below 25)
• You are likely to need ECT treatment during the course of the study

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