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 must be able to give written consent to participate in the study.
• You must have been diagnosed with a long-term (2 years or more) depressive episode, based on standard medical guidelines (DSM-5).
• You must have tried four or more antidepressant medications from at least two different types of antidepressants in your current depressive episode without enough improvement.
• You must have either received ECT (a treatment using electrical currents to the brain) or declined it if your doctor recommended it.
• You must score 20 or higher on a standard depression rating scale (called the HRSD) when you enter the study.
• You must be able to complete all required study assessments, including brain imaging scans (fMRI) and brain activity recording sessions (EEG).
• You must be under the regular care of a licensed psychiatrist and let the study team know if your care team changes at any point.
• You must agree to allow study staff to communicate with any of your current or recent healthcare providers.
• You must provide the names and contact details of at least two people aged 22 or older who live within a 30-minute drive of you and who can be contacted by study staff if needed.
• You must be enrolled in a Medicare program.

Who may not be able to join:

• If the study's surgical procedure would carry too great a medical or surgical risk for you, based on the investigator's judgment, you may not be eligible.
• You may not be able to join if you cannot have a full-body MRI scan.
• You may not be eligible if you are considered to be at acute (immediate) risk of suicide — for example, if you have made a suicide attempt or specific plans in the 30 days before the procedure, or if you score very high on a suicide risk scale.
• You may not be eligible if, in the past 12 months, you have made a suicide attempt that needed medical treatment, made two or more suicide attempts, have a specific suicide plan and cannot commit to seeking help if the urge to act on it becomes strong, or are considered likely to attempt suicide in the next six months (confirm with trial site).
• You may not be eligible if you have a history of schizophrenia, schizoaffective disorder, another psychotic disorder, or a current depressive episode that includes psychotic features (such as hallucinations or delusions).
• You may not be eligible if you have been diagnosed with dementia and score 23 or below on a standard memory and thinking test (called the MMSE).
• You may not be eligible if you have a positive pregnancy test.
• You may not be eligible if you test positive for drugs in a urine screen.
• You may not be eligible if you already have a deep brain stimulator (DBS) device implanted.
• You may not be eligible if you have a vagus nerve stimulator (VNS) device that was active within the last 6 months.
• You may not be eligible if you have a history of seizures.
• You may not be eligible if a surgical safety review of your brain scan shows age-related or medical brain changes that could make surgery unsafe (confirm with trial site).

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