Major Depressive Disorder study: Stimulation-ON vs Stimulation-OFF
Official title Closed-Loop Deep Brain Stimulation for Major Depression
ClinicalTrials.gov ID: NCT04004169
What this study is testing
- What it's testing
- This study is testing whether a personalized brain‑stimulation device can safely and effectively reduce depression symptoms.
- Who it's for
- You may be able to join if you have major depression that has not improved with other treatments.
- What's involved
- You will have a small device implanted in your brain. The device will monitor your brain activity and send gentle electric pulses when needed. You will visit the clinic for check‑ins and to adjust the device settings.
- Time commitment
- The study lasts about one year, with regular clinic visits and ongoing monitoring of your brain activity.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- Age 22-70
- Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for Major Depressive Disorder (MDD) without psychosis...
- Failed electroconvulsive therapy (ECT) due to inability to achieve sustained response (2 failed attempts to discontinue ECT treatment) or...
- 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...
You likely can't join if
- Meets DSM-V criteria for a psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, bipolar disorder, obsessive compulsive...
- 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
See the full eligibility criteria
Who can join
- Age 22-70
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.