San Francisco, CANCT04004169Now EnrollingIRB Ready

Major Depressive Disorder Clinical Trial in San Francisco, CA

Access cutting-edge major depressive disorder treatment through this clinical trial at a research site in San Francisco. Study-provided care at no cost to qualified participants.

Sponsored by Andrew Krystal

Quick Self-Assessment

See if you qualify for this San Francisco location

Preparing your pre-screening questions…

Expert Care in San Francisco

Access major depressive disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related major depressive disorder treatment provided free

Apply for This San Francisco Location

Check if you qualify for this major depressive disorder clinical trial in San Francisco, CA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to San Francisco

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit San Francisco site if eligible
  4. 4Begin participation

About This Major Depressive 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 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 depression.

Sponsor: Andrew Krystal

Who Can Participate

Inclusion Criteria

Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for Major Depressive Disorder (MDD) without psychosis based on a Structured Clinical Interview for DSM-V (SCID) with current episode ≥ 2 years that is treatment- resistant (4 adequate trials (including ECT), 3 classes of medications, one augmentation strategy, psychotherapy) as measured by the antidepressant treatment history form (ATHF).
Failed electroconvulsive therapy (ECT) due to inability to achieve sustained response (2 failed attempts to discontinue ECT treatment) or discontinued due to intolerable side effects.
Has MADRS score of \> 26 at both baseline and screening visit
The presence of variability on repeated administrations of MDD rating scales (minimum of 2-point variation on the HAMD-6 administered 3 times a day for 3 days), which is required for the identification of a neural biomarker.
If patient is on a regimen of psychotropic medication, no changes in this regimen should be made 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, bipolar 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
Women who are pregnant, plan to become pregnant, or breast feeding
Inability to speak and/or read English
Inability to give consent
Significant cognitive impairment or dementia (MoCA \< 25)
Likely to require ECT during the course of the study

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 (NCT04004169) 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.

Major Depressive Disorder Treatment Options in San Francisco, CA

If you're searching for major depressive disorder treatment options in San Francisco, CA, this clinical trial (NCT04004169) 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 major depressive 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 major depressive disorder clinical trials near you to find additional studies recruiting in your area.

More Depression Trials in San Francisco, CA

See all depression clinical trials recruiting in San Francisco — not just this study.

Browse Depression Trials in San Francisco →

Browse More Trials by Condition

Depression TrialsMajor Depressive Disorder TrialsAll Conditions →

Ready to Join in San Francisco?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · San Francisco, CA