Status:
COMPLETED
Deciphering Principles of Network Dynamics Underlying Depression Symptom Severity From Multi-day Intracranial Recordings in Patients With Major Depression
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
22-70 years
Brief Summary
Major depressive disorder (MDD) is common and causes significant disability world-wide. While typically responsive to medications and therapy, there remain a subset of patients who are treatment resis...
Detailed Description
Background: Major depression (MDD) is a leading cause of disability worldwide, with high rates of treatment resistance. This speaks strongly for the need to improve our understanding of the causes an...
Eligibility Criteria
Inclusion
- Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder (MDD) without psychosis based on a Structured Clinical Interview for DSM-V (SCID)
- Current episode ≥ 2 years
- Treatment-resistant (4 adequate trials including electroconvulsive therapy (ECT)), 3 classes of medications, one augmentation strategy, psychotherapy) as measured by the antidepressant treatment history form (ATHF)
- Failed ECT due to inability to achieve sustained response (2 failed attempts to discontinue ECT treatment) or discontinued due to intolerable side effects
- Montgomery Asberg Depression Rating Scale (MADRS) score of \> 26 at both baseline and screening visit
- Presence of variability on repeated administrations of depression 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
- No changes to psychotropic medication regimen 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
- 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 MI, 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
- 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 (Montreal Cognitive Assessment (MoCA) \< 25)
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06953362
Start Date
January 1 2021
End Date
December 31 2024
Last Update
May 1 2025
Active Locations (1)
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1
UCSF
San Francisco, California, United States, 94143