Bipolar Disorder 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 are between 22 and 70 years old
• You have been diagnosed with Bipolar II Disorder and have been experiencing a depressive episode lasting at least 1 year that has not responded to treatments
• You have not had a manic or hypomanic (elevated mood) episode in the last 2 years
• You are currently taking a mood-stabilizing or antipsychotic medication at a stable dose for at least 2 weeks, and are willing to continue taking it throughout the study
• You have either tried electroconvulsive therapy (ECT/shock therapy) but couldn't tolerate or sustain it, were unable to complete it due to side effects, or were advised to have ECT but were unwilling or unable to receive it
• You score above 26 on a standard depression rating scale at two separate check-in visits (confirm with trial site)
• Your psychiatric medication has not changed in the 4 weeks before joining and is not expected to change during the study
• You are willing and able to take part in a study involving brain recording and stimulation (an invasive procedure)
• You are willing and able to attend multiple research visits and follow a research routine at home
• You are willing and able to give your informed consent to participate
• You can speak and read English

Who may not be able to join:

• You have a diagnosis of a psychotic disorder, eating disorder, panic disorder, PTSD, OCD, tic disorder, or another significant psychiatric condition beyond depression or generalized anxiety disorder
• Your main current diagnosis is generalized anxiety disorder rather than depression
• You are currently having thoughts of suicide with a specific plan and intent
• You have been hospitalized due to a suicide attempt in the last 2 years
• You have had problems with alcohol or substance misuse (other than caffeine) in the last 6 months
• You have a personality disorder that the study team believes could affect your safety or ability to follow the study rules
• You have fibromyalgia or chronic fatigue syndrome
• You currently need to take strong prescription pain medications (narcotics) on an ongoing basis
• You have a history of traumatic brain injury, a neurological condition, or a developmental delay
• You have a history of seizures
• You have had a brain MRI within the last year that showed significant abnormalities
• You have previously had brain surgery to remove or destroy tissue, or currently have a deep brain stimulation device or other brain stimulation implant
• You have any implanted medical device that is not compatible with MRI or with this study's equipment
• You have serious medical conditions that increase the risk of surgery, such as severe diabetes, major organ failure, history of bleeding stroke, need for blood thinners (other than aspirin), active infection, certain brain or heart conditions, a weakened immune system, or a cancer diagnosis with a life expectancy of less than 5 years (confirm with trial site for full list)
• You are unable to safely stop blood-thinning or anti-clotting medications for surgery (you would need to discuss this with your doctor and the study team)
• You have a blood clotting disorder, unless you have been reviewed and cleared by a blood specialist
• You have known allergies or sensitivities to materials used in the study device, including titanium, polyurethane, silicone, or stainless steel
• You live alone with no one available to support you after leaving the hospital
• You are unable to attend the required follow-up visits during the study

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