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:

• People who have been diagnosed with depression lasting at least two years, or depression that has come back multiple times, and who are currently going through a major depressive episode.
• People whose depression symptoms score at least 20 on a standard depression rating scale called the MADRS, measured before treatment begins.
• People whose current depressive episode has not responded in a lasting way to at least two adequately dosed antidepressant medications from at least two different medication types.
• People who have completed all required pre-surgery assessments, including CT and MRI brain scans and thinking/memory tests, done approximately two and three weeks before the expected surgery date.
• People who are between 21 and 80 years of age.
• People who are able to complete all study evaluations, including high-resolution CT and MRI brain scans.
• People who are able to give written informed consent and have signed the study consent form.
• Female participants who are not pregnant, who are not able to become pregnant (for example, after menopause, or following certain surgical procedures), or who agree to use adequate birth control during the study.

Who may not be able to join:

• People for whom the implant surgery would carry an unacceptable medical or surgical risk, as judged by the study investigator.
• People who are expected to need a full-body MRI scan at any point during the study.
• People who, within the 30 days before the planned surgery, have attempted or planned suicide, as determined by the study investigator.
• People who have a history of schizophrenia, schizoaffective disorder, or another psychotic disorder, or whose current depressive episode includes psychotic features.
• People who have a neurological condition such as epilepsy, dementia, delirium, amnesia, or significant cognitive (thinking and memory) difficulties.
• People who have a history of a brain injury that caused cognitive impairment.
• People who have a history of bone density disorders, as this may affect the safe use and placement of the device.
• Female participants who test positive for pregnancy on a urine test.
• People who are currently taking a type of antidepressant medication called an MAO inhibitor (such as Isocarboxazid, Phenelzine, Selegiline, or Tranylcypromine), if this poses a risk with general anaesthesia (confirm with trial site).
• People — or whose psychiatrist — are not willing to keep their current psychiatric medications unchanged for four months after enrolling in the study.
• People who have a specific structural change in the frontal bone of the skull (called hyperostosis frontalis interna, where the bone is thicker than 20mm) at the planned site of the implant, as identified by a CT scan.

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