Treatment Resistant DepressionNCT06953362
Deciphering Principles of Network Dynamics Underlying Depression Symptom Severity From Multi-day Intracranial Recordings in Patients With Major Depression
An observational study of Treatment Resistant Depression, run by University of California, San Francisco at 1 site in United States.
Trial 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 resistant. Novel approaches are critical to treat these patients. Read more about this study
- Who is it for?
- Ages 22 months to 70 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Direct Neural Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 6 Individuals meeting the inclusion/exclusion criteria who are participating in the PRESIDIO trial of personalized intracranial closed-loop stimulation for treatment of treatment-resistant major depression.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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 resistant. Novel approaches are critical to treat these patients. MDD is likely caused by dysfunction in distributed neural networks, a perspective consistent with the etiological and diagnostic heterogeneity of this disorder. While imaging and electroencephalography (EEG) have helped identify MDD circuitry, no consensus has been reached on the identification of diagnostic biomarkers. Furthermore, the dynamics of MDD circuitry in relation to symptom severity is unknown. Characterization of circuit signatures that define MDD symptom severity states and the extent to which these circuits are modifiable using electrical stimulation are critical for therapeutic advancement. Intracranial EEG (iEEG) offers a high spatial and temporal resolution method to study depression networks. For the first time, we have an unparalleled opportunity to study such circuits in MDD patients participating in a clinical trial of personalized responsive neurostimulation for treatment resistant depression (PRESIDIO). In stage 1 of this trial, participants are implanted with 160 electrodes from 10 sub-chronic intracranial leads across 10 brain sites for 10 days. The goal of this parent study stage is to optimize brain-site targeting for deep brain stimulation. In the current project, we will leverage the opportunity to study MDD circuit principles from cortical and deep brain structures over a multi-day time period. In this ancillary study to the parent clinical trial, we carry out a set of experiments that establish basic principles of network dynamics underlying MDD from direct neural recordings. This study is organized around the principal concept that brain circuit dysfunction is reflected in abnormal signatures of functional connectivity and rhythmic local-field activity. This concept is supported by our pilot work where we found evidence of distinct MDD networks characterized by functional connectivity and spectral activity. This project builds on our preliminary findings in two aims. In Aim 1, we characterize state-dependent functional connectivity and spectral activity in relation to symptom severity. In Aim 2, we will examine the manner and time course in which targeted electrical stimulation acutely modifies circuits. Together, this research will yield the first characterization of connectivity and activity dynamics in MDD over a multi-day period from direct neural recordings. This rare insight into MDD circuity provided by this novel dataset establishes proof-of-concept principles for biomarker development and therapeutic target selection that could critically advance personalized MDD treatments.
Read the 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 and underlying neurobiology of this condition so that we can developed improved treatments. Our current understanding of MDD is quite limited. However, available evidence points to dysfunction in distributed neural networks, a perspective consistent with the etiological and diagnostic heterogeneity of this disorder. While imaging and electroencephalography (EEG) have helped identify MDD circuitry, no consensus has been reached on the identification of diagnostic biomarkers. Furthermore, the dynamics of MDD circuitry in relation to symptom severity is unknown. Whether there are neural signatures of circuits that define MDD symptom severity states and the extent to which these circuits are modifiable using direct electrical stimulation are unanswered questions critical for therapeutic advancement.
Intracranial EEG (iEEG) offers a promising high-resolution method to study network fundamentals and help elucidate the neural dysfunction underlying MDD. For the first time, we have the opportunity to use this technique to study circuits in MDD in patients participating in a clinical trial of personalized responsive neurostimulation for treatment resistant depression (PRESIDIO). In stage 1, participants are implanted with 160 electrodes across 10 brain sites for 10 days to target brain site placement of chronic deep brain stimulation leads in stage 2. This stage offers the unique opportunity to study principles of MDD circuits from cortical and deep brain structures over a multi-day time period. The current study capitalizes on that opportunity. It is an ancillary study to the PRESIDIO trial where we will have the opportunity to perform a set of experiments that establish basic principles of network dynamics underlying MDD from direct neural recordings.
This project is organized around the principal concept that brain circuit dysfunction is reflected in abnormal signatures of functional connectivity and rhythmic local-field activity. The overarching objective is to establish proof-of concept for two fundamental principles of circuit function in depression: i) that circuit features are related to MDD symptom severity, and ii) that perturbation with focal electrical stimulation can acutely modify these circuits. Our rationale for this study is based on: 1) preliminary work, in which we identified a set of connectivity and activity features that were predictive of a diagnosis of co-morbid depression in patients with epilepsy; 2) published work by our group that found targeted stimulation acutely changes mood and spectral power across a broad network in patients with epilepsy; and 3) pilot data for this proposal in which we establish proof-of-concept that MDD symptom severity states can be defined using a 6-question version of the Hamilton Depression Rating Scale (HAMD6). It remains unknown whether circuit features identified in an epilepsy population are generalizable to patients with MDD in the absence of epilepsy, and the manner in which these neural features vary with symptom states - questions we can address in this proposal. We hypothesize that a set of neural connectivity and activity features will characterize symptom severity states in MDD implicating their potential to serve as a state vs. trait MDD biomarker, and that circuit features can be acutely modified by brain stimulation indicating their potential to serve as a therapy target.
Goals:
- Aim 1. Biomarker Development: Characterize the pattern of network connectivity and activity that is associated with symptom severity. The objective of this goal is to establish proof-of concept that circuit features are related to major depressive disorder (MDD) symptom severity. Our working hypothesis is that spectral activity and connectivity within and across the amygdala, hippocampus, SGC, OFC, and VC will capture the majority of variance in MDD symptom severity. The rationale behind this goal is preliminary work that implicates corticolimbic circuit features in diagnostic biomarkers in MDD, and our pilot data showing features to be predictive of symptom state.
- Aim 2. Acute Change with Circuit Perturbation: Characterize the capacity for brief (2-10 min) periods of targeted electrical stimulation to acutely modify connectivity and activity. The objective of this goal is to establish proof-of-concept that targeted electrical stimulation can acutely modify circuit activity and connectivity features indicating their potential to serve as therapy targets. Our working hypothesis is that graph theoretic properties of MDD network nodes will distinguish their capacity to affect network connectivity and activity following stimulation. The rationale is work by our group that found stimulation to corticolimbic targets acutely changed spectral power across a network, and that nodal properties exert predictive effects of stimulation on networks in epilepsy. A node with high outdegree is a hub of high network influence and could be indicative of a good treatment target. In contrast, a node with high indegree suggests a region that is influenced by stimulation in other regions and may play a role in sensing modifiable neural signatures of MDD.
- Conditions
- Treatment Resistant Depression
- Being tested
- Direct Neural Electrical Stimulation
- Keywords
- Major Depression, Treatment Resistant Depression, Neural Network Dynamics
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Neural Electrical StimulationDevice
We are not delivering treatment in this study. Direct neural electrical stimulation is being administered to determine its effect on neural circuit activity and connectivity.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | No treatment is being administered in this study. Direct neural electrical stimulation is being administered across a large number of sites in the corticolimbic network in order to determine its effects on neural network electrical activity and connectivity. Receives: Device: Direct Neural Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Network Connectivity and Activity Pattern: Relationship to Symptom Severity and Impact of Neurostimulation
The pattern of network connectivity and activity that is associated with symptom severity and the effect of intracranial electrical stimulation on the connectivity and activity pattern.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Andrew Krystal, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953362
- Sponsor's protocol ID
- 5R21MH124759
- Other IDs
- 5R21MH124759
- Status last verified
- Apr 2025
- First submitted
- 16 Nov 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the values of the variables for all published findings, will be added to a data archive. This data archive will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. The data will be accompanied by a file including documentation of the data archive including information about the methodology and procedures used to collect the data, definitions of variables, and variable field locations. This file will also state the requirement that users submit an email notification of the intent to access the data and that any publications using these data acknowledge the source of the data. Should any intellectual property arise from the proposed study that may be patentable, UCSF will ensure that the related technology remains widely available in timely fashion to the research community in compliance with policies and regulations governing research awards from the NIH
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering Principles of Network Dynamics Underlying Depression Symptom Severity From Multi-day Intracranial Recordings in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT06953362
- Acronym / sponsor ID
- 5R21MH124759
- Conditions
- Treatment Resistant Depression
- Keywords
- Major Depression, Treatment Resistant Depression, Neural Network Dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 resistant. Novel approaches are critical to treat these patients. MDD is likely caused by dysfunction in distributed neural networks, a perspective consistent with the etiological and diagnostic heterogeneity of this disorder. While imaging and electroencephalography (EEG) have helped identify MDD circuitry, no consensus has been reached on the identification of diagnostic biomarkers. Furthermore, the dynamics of MDD circuitry in relation to symptom severity is unknown. Characterization of circuit signatures that define MDD symptom severity states and the extent to which these circuits are modifiable using electrical stimulation are critical for therapeutic advancement. Intracranial EEG (iEEG) offers a high spatial and temporal resolution method to study depression networks. For the first time, we have an unparalleled opportunity to study such circuits in MDD patients participating in a clinical trial of personalized responsive neurostimulation for treatment resistant depression (PRESIDIO). In stage 1 of this trial, participants are implanted with 160 electrodes from 10 sub-chronic intracranial leads across 10 brain sites for 10 days. The goal of this parent study stage is to optimize brain-site targeting for deep brain stimulation. In the current project, we will leverage the opportunity to study MDD circuit principles from cortical and deep brain structures over a multi-day time period. In this ancillary study to the parent clinical trial, we carry out a set of experiments that establish basic principles of network dynamics underlying MDD from direct neural recordings. This study is organized around the principal concept that brain circuit dysfunction is reflected in abnormal signatures of functional connectivity and rhythmic local-field activity. This concept is supported by our pilot work where we found evidence of distinct MDD networks characterized by functional connectivity and spectral activity. This project builds on our preliminary findings in two aims. In Aim 1, we characterize state-dependent functional connectivity and spectral activity in relation to symptom severity. In Aim 2, we will examine the manner and time course in which targeted electrical stimulation acutely modifies circuits. Together, this research will yield the first characterization of connectivity and activity dynamics in MDD over a multi-day period from direct neural recordings. This rare insight into MDD circuity provided by this novel dataset establishes proof-of-concept principles for biomarker development and therapeutic target selection that could critically advance personalized MDD treatments.
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 and underlying neurobiology of this condition so that we can developed improved treatments. Our current understanding of MDD is quite limited. However, available evidence points to dysfunction in distributed neural networks, a perspective consistent with the etiological and diagnostic heterogeneity of this disorder. While imaging and electroencephalography (EEG) have helped identify MDD circuitry, no consensus has been reached on the identification of diagnostic biomarkers. Furthermore, the dynamics of MDD circuitry in relation to symptom severity is unknown. Whether there are neural signatures of circuits that define MDD symptom severity states and the extent to which these circuits are modifiable using direct electrical stimulation are unanswered questions critical for therapeutic advancement.
Intracranial EEG (iEEG) offers a promising high-resolution method to study network fundamentals and help elucidate the neural dysfunction underlying MDD. For the first time, we have the opportunity to use this technique to study circuits in MDD in patients participating in a clinical trial of personalized responsive neurostimulation for treatment resistant depression (PRESIDIO). In stage 1, participants are implanted with 160 electrodes across 10 brain sites for 10 days to target brain site placement of chronic deep brain stimulation leads in stage 2. This stage offers the unique opportunity to study principles of MDD circuits from cortical and deep brain structures over a multi-day time period. The current study capitalizes on that opportunity. It is an ancillary study to the PRESIDIO trial where we will have the opportunity to perform a set of experiments that establish basic principles of network dynamics underlying MDD from direct neural recordings.
This project is organized around the principal concept that brain circuit dysfunction is reflected in abnormal signatures of functional connectivity and rhythmic local-field activity. The overarching objective is to establish proof-of concept for two fundamental principles of circuit function in depression: i) that circuit features are related to MDD symptom severity, and ii) that perturbation with focal electrical stimulation can acutely modify these circuits. Our rationale for this study is based on: 1) preliminary work, in which we identified a set of connectivity and activity features that were predictive of a diagnosis of co-morbid depression in patients with epilepsy; 2) published work by our group that found targeted stimulation acutely changes mood and spectral power across a broad network in patients with epilepsy; and 3) pilot data for this proposal in which we establish proof-of-concept that MDD symptom severity states can be defined using a 6-question version of the Hamilton Depression Rating Scale (HAMD6). It remains unknown whether circuit features identified in an epilepsy population are generalizable to patients with MDD in the absence of epilepsy, and the manner in which these neural features vary with symptom states - questions we can address in this proposal. We hypothesize that a set of neural connectivity and activity features will characterize symptom severity states in MDD implicating their potential to serve as a state vs. trait MDD biomarker, and that circuit features can be acutely modified by brain stimulation indicating their potential to serve as a therapy target.
Goals:
- Aim 1. Biomarker Development: Characterize the pattern of network connectivity and activity that is associated with symptom severity. The objective of this goal is to establish proof-of concept that circuit features are related to major depressive disorder (MDD) symptom severity. Our working hypothesis is that spectral activity and connectivity within and across the amygdala, hippocampus, SGC, OFC, and VC will capture the majority of variance in MDD symptom severity. The rationale behind this goal is preliminary work that implicates corticolimbic circuit features in diagnostic biomarkers in MDD, and our pilot data showing features to be predictive of symptom state.
- Aim 2. Acute Change with Circuit Perturbation: Characterize the capacity for brief (2-10 min) periods of targeted electrical stimulation to acutely modify connectivity and activity. The objective of this goal is to establish proof-of-concept that targeted electrical stimulation can acutely modify circuit activity and connectivity features indicating their potential to serve as therapy targets. Our working hypothesis is that graph theoretic properties of MDD network nodes will distinguish their capacity to affect network connectivity and activity following stimulation. The rationale is work by our group that found stimulation to corticolimbic targets acutely changed spectral power across a network, and that nodal properties exert predictive effects of stimulation on networks in epilepsy. A node with high outdegree is a hub of high network influence and could be indicative of a good treatment target. In contrast, a node with high indegree suggests a region that is influenced by stimulation in other regions and may play a role in sensing modifiable neural signatures of MDD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | – | Device: Direct Neural Electrical StimulationNo treatment is being administered in this study. Direct neural electrical stimulation is being administered across a large number of sites in the corticolimbic network in order to determine its effects on neural network electrical activity and connectivity. |
Who may qualify
- Ages
- 22 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 6 Individuals meeting the inclusion/exclusion criteria who are participating in the PRESIDIO trial of personalized intracranial closed-loop stimulation for treatment of treatment-resistant major depression.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Neural Electrical StimulationWe are not delivering treatment in this study. Direct neural electrical stimulation is being administered to determine its effect on neural circuit activity and connectivity. | Device | All Subjects |
Primary outcome
Network Connectivity and Activity Pattern: Relationship to Symptom Severity and Impact of Neurostimulation
Time frame: Up to 10 days
The pattern of network connectivity and activity that is associated with symptom severity and the effect of intracranial electrical stimulation on the connectivity and activity pattern.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. All the values of the variables for all published findings, will be added to a data archive. This data archive will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. The data will be accompanied by a file including documentation of the data archive including information about the methodology and procedures used to collect the data, definitions of variables, and variable field locations. This file will also state the requirement that users submit an email notification of the intent to access the data and that any publications using these data acknowledge the source of the data. Should any intellectual property arise from the proposed study that may be patentable, UCSF will ensure that the related technology remains widely available in timely fashion to the research community in compliance with policies and regulations governing research awards from the NIH
Related trials for Treatment Resistant Depression
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Treatment-resistant Depression (TRD)
RecruitingPhase 3
InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression
Treatment Resistant Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Krystal, MD, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Resistant Depression, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Network Connectivity and Activity Pattern: Relationship to Symptom Severity and Impact of Neurostimulation (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.