Depression and Anxiety Trial, Recruiting

Written by an AI model from the 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 between the ages of 22 and 64 (inclusive), of any gender
• People who have been diagnosed with Bipolar I disorder and are currently going through a major depressive episode, confirmed by a structured clinical interview
• People whose depression symptoms are rated as severe enough on standard clinical rating scales at the screening and pre-surgery visits
• People whose first mood episode occurred before the age of 40
• People who have tried at least four evidence-based treatments for bipolar depression over their lifetime — including at least two medications approved for this use (such as quetiapine, lurasidone, cariprazine, or others) — without adequate or lasting benefit, and who have also tried at least two of these approved treatments during their current episode without adequate benefit
• People who are currently taking at least one established medication for bipolar disorder (such as lithium or an antipsychotic), unless no such medications have been tolerated
• People who have been on a stable dose of their psychiatric medications for at least four weeks before surgery
• People who score at or above a minimum level on a standard memory and thinking assessment (confirm with trial site for exact score required)
• People who are able and willing to give informed consent and agree to a treatment contract, including identifying a reliable person who can provide information about them

Who may not be able to join:

• People with a lifetime history of a psychotic disorder (such as schizophrenia or schizoaffective disorder), or any history of psychotic symptoms that occurred outside of a bipolar mood episode
• People who are currently experiencing a manic or hypomanic episode, or who have had four or more mood episodes in the past 12 months
• People whose primary psychiatric treatment focus in the past 12 months has been a condition other than bipolar disorder
• People with a moderate or severe alcohol or substance use disorder within the past 12 months (not including nicotine)
• People with an intellectual disability or a significant disorder affecting memory and thinking
• People with serious or unstable physical health conditions, such as significant liver, kidney, or heart problems, active infections, cancer, certain neurological disorders (such as epilepsy, stroke, or dementia), or other major medical issues
• People for whom surgery would not be considered safe, in the opinion of the surgeon
• People who are pregnant, breastfeeding, or planning to become pregnant within the next 24 months
• People for whom MRI scanning is not safe or suitable
• People with a significant personality disorder that, in the investigator's opinion, would meaningfully affect their current mental health status or safe participation in the study
• People considered by the investigators to be at serious and immediate risk of suicide and therefore not suitable for an outpatient study
• People who have participated in another investigational clinical trial within the past 30 days
• People who currently have an implanted stimulation device, such as a cardiac pacemaker, defibrillator, or nerve stimulator
• People who do not have regular contact with at least one other adult, or who do not have stable housing
• People with a body mass index (a measure of body weight relative to height) below 16 or above 40
• People who require a medical procedure called diathermy (a heat-based treatment)
• People who are unable to sign the informed consent form for any reason
• People who are not under the ongoing care of a psychiatrist at the time of screening and throughout the study

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