NCT06002100
Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
Enrolling by Invitation
Not specifiedAges 18–75ObservationalKernel
~540 participants
Updated 2025-12-12 on ClinicalTrials.gov
What's tested:fNIRS measurement
At a glance
Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brain hemodynamic activity with TD-fNIRS
Measured over Approximately 30 minutes during each study visit
+3 more outcomes measured
Conditions
Where it's being run
10 sites across 3 statesCalifornia7
Washington2
Ohio1
Study leadership
- Katherine Perdue, PhD · PRINCIPAL_INVESTIGATOR · Kernel
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Adult between the ages of 18 - 65, inclusive at time of enrollment
Primary diagnosis of MDD as defined by DSM-5
Determined by clinic to be eligible for ketamine treatment and agrees to receive ketamine treatment
Agrees to start ketamine treatment in conjunction with study participation to capture pre-treatment measurements accurately
Has not received a ketamine treatment course in the past 12 months
Has not received a TMS treatment course in the past 3 months
Ability to consent for themselves
Fluency in English (speaking and reading)
Adult between the ages of 18 - 75, inclusive at time of enrollment
Primary diagnosis of MDD as defined by DSM-5
Determined by clinic to be eligible for SPRAVATO treatment and agrees to receive SPRAVATO treatment
Agrees to start SPRAVATO treatment in conjunction with study participation to capture pre-treatment measurements accurately
Has not received a ketamine or SPRAVATO treatment course in the past 12 months
Has not received a TMS treatment course in the past 3 months
Ability to consent for themselves
Fluency in English (speaking and reading)
Adult between the ages of 18 - 65, inclusive at time of enrollment
Primary diagnosis of MDD as defined by DSM-5
Determined by clinic to be eligible for TMS treatment and agrees to receive TMS treatment
Agrees to start TMS treatment in conjunction with study participation to capture pre-treatment measurements accurately
Has not received a TMS treatment course in the past 12 months
Has not received a ketamine or SPRAVATO treatment course within the last 3 months
Ability to consent for themselves
Fluency in English (speaking and reading)
Adult between the ages of 18 - 65, inclusive at time of enrollment
Primary diagnosis of MDD as defined by DSM-5
Determined by clinic to be eligible for antidepressant treatment and agrees to receive antidepressant treatment
Agrees to start antidepressant treatment in conjunction with study participation to capture pre-treatment measurements accurately
Has not taken antidepressants in the past 3 months
Has not received a TMS, SPRAVATO, or ketamine treatment course in the past 3 months
Ability to consent for themselves
Fluency in English (speaking and reading)
Exclusion
Is or may be pregnant (for participant of childbearing potential \[POCBP\]), even if they have been cleared to receive the depression treatment
Unable or unwilling to wear the TD-fNIRS headset
Has had ECT in the past 3 months
Major visual or auditory deficits that would prevent study task completion
Hospitalizations and/or unstable health/medical condition/treatment in the last 30 days
Major medical illnesses and psychiatric conditions including:
Alzheimer's/Mild Cognitive Impairment
Parkinson's disease
Motor neuron diseases
Multiple Sclerosis
Brain Tumor
Stroke
Encephalitis
Meningitis
Epilepsy
TBI with serious results (coma, unconscious for \>2 hrs, or skull fracture)
Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)
Any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
Not an appropriate candidate for the study in the judgment of the investigator(s)
What this trial measures
- Brain hemodynamic activity with TD-fNIRSApproximately 30 minutes during each study visit
This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.
- Optical properties of the brain with TD-fNIRSApproximately 30 minutes during each study visit
This measures how much light is absorbed at different points on the head.
- Physiological features with TD-fNIRSApproximately 30 minutes during each study visit
This includes cardiac measures, such as heart rate (HR).
- Physiological features with TD-fNIRSApproximately 30 minutes during each study visit
This includes cardiac measures, such as heart rate variability (HRV).