Epilepsy 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:

• Men and women (not currently pregnant) between the ages of 22 and 70
• People who have been formally diagnosed with major depressive disorder (MDD) as their main diagnosis, currently experiencing a depressive episode, without any psychotic features
• People whose current depressive episode has lasted at least 24 months, or who have had at least 2 episodes in their lifetime with the current one lasting more than 12 months
• People whose depression has not responded to at least four adequate treatments from at least two different categories of antidepressants or related medications
• People who have previously tried electroconvulsive therapy (ECT) and either did not respond, relapsed, did not tolerate it well, or declined it
• People whose depression symptoms are rated at a certain level of severity on two standard clinical rating scales, measured at screening and again about one week before any surgery
• People who have previously tried at least 6 weeks of psychotherapy without lasting improvement
• People who have had a brain MRI within 3 months of joining the study that shows no findings that would prevent participation, according to the treating doctor
• People who have been on a stable antidepressant medication plan for at least one month before surgery
• People who score at or above a certain level on a standard memory and thinking test (a score of 24 or higher)
• People who have had a normal thyroid hormone (TSH) test result within the past 12 months
• People whose overall health, in the treating doctor's opinion, allows them to take part for the full length of the study
• People who are willing and able to give informed consent and attend regular clinic visits for at least 12 months after surgery
• People who have a psychiatrist, family member, partner, caregiver, or other known person present at the screening visit to discuss the study before consent is signed
• People who are willing to sign a treatment agreement and agree to be followed regularly by a licensed psychiatrist throughout the study
• People who agree to allow the research team to communicate with their other healthcare providers throughout the study
• People who have had brain electrodes placed for clinical epilepsy assessment (confirm with trial site)

Who may not be able to join:

• People who have ever had a psychotic disorder, such as schizophrenia or schizoaffective disorder
• People with bipolar disorder involving rapid mood cycling and a history of a manic episode requiring hospitalisation within the past 5 years
• People with a clinically significant personality disorder in certain categories (Cluster A or B), as assessed by a clinician
• People who have had an alcohol or substance use disorder within the past 6 months (not including nicotine)
• People whose urine drug test is positive for illicit drugs
• People who have shown any signs of suicidal thoughts, plans, or behaviour within the past year
• People with a neurological or medical condition that, in the surgeon's opinion, makes surgery too risky (for example, a progressive brain disease or significant heart or lung problems)
• People with a history of seizures, bleeding stroke, or factors that increase seizure risk (such as brain injury, certain medications, or developmental brain conditions)
• People with any medical reason that would make surgery unsafe, such as an active infection
• People with blood clotting problems or certain abnormal blood test results related to clotting
• People with a blood pressure of 180/110 mmHg or higher at any single visit, combined with existing heart or cardiovascular disease
• People who have taken part in another drug, device, or biological trial within the past 90 days
• People who already have an implanted stimulation device, such as a pacemaker, defibrillator, or spinal cord or brain stimulator
• People who are pregnant or plan to become pregnant within the next 24 months
• People who are expected to need an MRI scan during the study period
• People who require a treatment called diathermy (a type of heat-based therapy)
• People who need ongoing blood-thinning medication that cannot be safely stopped for at least 2.5 weeks around the time of surgery
• People who, in the investigator's overall opinion, are not suitable candidates for any medical, psychiatric, or neurological reason

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