Fact CheckerSign in

NCT06002100Enrolling by invitation

Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements

PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements

Source: ClinicalTrials.gov · Last updated 12 Dec 2025

Brief summary (registry, in English)

The purpose of the current study is to perform a unified, homogeneous data collection protocol that includes a large cohort of patients undergoing different treatment options for Major Depressive Disorder (MDD) as an avenue for investigating optimal biomarkers for depression treatments on an individual patient level.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
540 (estimated)
First submitted
11 Aug 2023
Start date
14 Aug 2023
Primary completion date
Aug 2026
Lead sponsor
Kernel
Diseases
Depression
NCT number
NCT06002100

What you commit to

  • Study type: Observational
  • Planned participants: 540
  • From 14 Aug 2023 to the primary completion date, Aug 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • 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
  • Not an appropriate candidate for the study in the judgment of the investigator(s)

Who the study is looking for

  • Ketamine cohort
  • 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)
    • SPRAVATO cohort
  • 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)
    • TMS cohort
  • 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)
    • Antidepressants cohort
  • 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)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seattle Neuropsychiatric Treatment Center
Coordinator of this site? Confirm its status
BellevueUnited StatesUnknown status
Metro Psychiatry Inc.
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
BrainHealth Solutions
Coordinator of this site? Confirm its status
Costa MesaUnited StatesUnknown status
Kadima Neuropsychiatry Institute
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Kaizen Brain Center, LLC
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Bespoke Treatment
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
UCLA TMS
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Seattle Neuropsychiatric Treatment Center
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Acacia Clinics
Coordinator of this site? Confirm its status
SunnyvaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.