Is NCT07127913 recruiting in San Francisco, CA?

Yes, NCT07127913 is currently recruiting participants at its San Francisco, CA location. This bipolar ii disorder clinical trial is actively enrolling qualified participants.

How do I join the bipolar ii disorder clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Bipolar II Disorder Clinical Trial in San Francisco, CA

About This Bipolar II Disorder Study in San Francisco

Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for bipolar depression The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat bipolar depression.

Sponsor: Andrew Krystal

Who Can Participate

Inclusion Criteria

Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Bipolar II Disorder, with an episode of depression lasting at least 1 year that is treatment resistant as defined above, without a manic or hypomanic episode in the last 2 years; patients must be taking a mood stabilizer (lithium \>0.6 mEq/L or valproate \>350 mM/L), an atypical antipsychotic, or a combination of a mood stabilizer and an atypical antipsychotic for at least 2 weeks at a stable dosage before starting the study and must continue taking anti-manic medication throughout their participation in the study unless discontinuation is necessary because of patient safety/health considerations.

Must have either failed ECT (it was effective but not tolerated due to side effects; it was effective, but patients could not achieve a sustained response), not been able to complete a course of ECT due to side effects, or have been medically advised to receive ECT and have been unwilling or unable to obtain ECT.

Has MADRS score of \> 26 at two baseline visits

Ability to complete repeated administrations of MDD rating scales.

If patient is on a regimen of psychotropic medication, no changes in this regimen should be expected during the 4 weeks prior to entry into and the duration of the study.

Willing and able to undergo invasive brain recording/stimulation study

Willing and able to attend multiple research visits and perform at-home research protocol

Willing and able to provide informed consent

Ability to speak and read English

Exclusion Criteria

Meets DSM-V criteria for a psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, obsessive compulsive disorder, tic disorder, or another comorbid psychiatric disorder other than MDD or generalized anxiety disorder based on a SCID

Generalized anxiety disorder is the primary DSM-V disorder during the current MDD episode

Active suicidal ideation with intent and plan as defined by a score of 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)

History of suicide attempt requiring hospitalization in previous 2 years.

Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, determined by the SCID

Has a personality disorder based on the investigator's assessment that the investigator believes will adversely impact subject compliance or safety

Fibromyalgia or chronic fatigue syndrome

Current condition requiring chronic narcotic use

History of traumatic brain injury, another neurological disorder, or developmental delay

History of seizures

MRI (done within one year of the first visit) with significant abnormalities

Previous ablative intracranial surgery or previously implanted deep brain stimulation system or any previously implanted device treatment involving brain stimulation

Implantable hardware not compatible with MRI or with the study

Major medical co-morbidities increasing the risk of surgery including severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation other than aspirin, active infection, intracranial space occupying lesion, increased intracranial pressure, cardiovascular accident within the last month, aneurysm/abnormality, retinal detachment, unstable cardiovascular disease (recent myocardial infarction, severe ischemia, severe or uncontrolled hypertension), immunocompromised state, or malignancy with \< 5 years life expectancy

Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. - Patients taking these medications will need to discuss the need/risk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) to discuss the risks of anticoagulation/antiaggregation therapy discontinuation

Coagulopathy. Patients will be excluded unless assessed and cleared by hematology

Allergies or known hypersensitivity to materials in the NeuroPace RNS® System (i.e. titanium, polyurethane, silicone, polyetherimide, stainless steel)

Subject lives alone without possibility of caregiver support post-hospital stay

Inability to comply with study follow-up visits

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Francisco?

Yes, this clinical trial (NCT07127913) has an active research site in San Francisco, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Bipolar II Disorder Treatment Options in San Francisco, CA

If you're searching for bipolar ii disorder treatment options in San Francisco, CA, this clinical trial (NCT07127913) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Francisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced bipolar ii disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all bipolar ii disorder clinical trials near you to find additional studies recruiting in your area.

Bipolar II Disorder Clinical Trial in San Francisco, CA

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