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 have been diagnosed with Bipolar I or Bipolar II disorder and are currently going through a depressive episode, OR you have depression that has not improved despite trying at least two different antidepressant medications at proper doses for at least 6 weeks each.
• Your depression is considered severe, scoring above 19 on a standard depression rating scale called the Hamilton Depression Rating Scale (confirm with trial site).
• You are between 22 and 85 years old.
• You are male or female, of any race or ethnic background.
• You are able to understand and sign a consent form agreeing to take part in the study.
• You are able to follow the study's procedures and attend required appointments.
• If you are a woman who could become pregnant, you must have been using highly effective birth control for at least one month before joining and agree to continue using it during the study and for one week after treatment ends.
• If you are a man who could father a child, you must agree to use condoms or another reliable form of contraception during the study.
• You can read and understand English well enough to fill out self-rated questionnaires.
• You have been cleared as generally healthy by another doctor before starting the procedures.
• You have been on a stable dose of psychiatric medication for at least 6 weeks before entering the study.

Who may not be able to join:

• You have an implanted medical device that is controlled by body signals, such as a pacemaker, implanted heart defibrillator, vagus nerve stimulator, deep brain stimulator, implanted medication pump, or wearable defibrillator.
• You have any metal implants in your head or within about 12 inches of the treatment device, such as stents or bullet fragments (note: standard dental fillings are generally acceptable — confirm with trial site).
• You have a brain condition caused by injury, infection, blood vessel problems, or a metabolic disorder.
• You currently have a sleep deprivation problem or alcoholism.
• You have a current substance use disorder (other than nicotine or caffeine) that has not been in stable remission for at least 6 months.
• You are currently pregnant or breastfeeding.
• You have a history of epilepsy or unexplained seizures.
• You have a history of a growth or mass inside the skull.
• You have a medical condition that makes bleeding likely, such as a blood clot under the skull (subdural hematoma) or a weakened area in a major blood vessel (aortic aneurysm).
• You have a degenerative brain condition such as dementia, or another illness that significantly affects brain function.
• You have significant heart problems or other medical conditions that make anesthesia unsafe for you.
• Your Body Mass Index (BMI) is over 60.
• You have a severe personality disorder (such as borderline personality disorder) that, in the investigators' judgment, would prevent you from completing the study.
• You are considered to be at immediate risk of suicide, including having a specific plan, current suicidal thoughts, or being unlikely to seek help if needed (based on the investigators' judgment).
• You have a terminal illness with an expected survival of less than 12 months.
• Your bipolar depression includes psychotic features (such as hallucinations or delusions).
• You have a known allergy to any anesthetic medications used in this study, including succinylcholine, methohexital, ketamine, propofol, or ketorolac.
• You have taken part in another clinical trial for a drug, device, or biological treatment within the past 30 days.
• You are currently taking anti-epileptic medications or certain benzodiazepines that cannot be safely adjusted before treatment (confirm with trial site for specifics about your medications).
• You are currently taking lithium, as it would need to be gradually reduced before the procedure due to safety concerns (confirm with trial site).
• You are unable or unwilling to meet the operational and administrative requirements of the study, in the investigators' judgment.

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