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

Part of paid clinical trials in Costa Mesa, California.

Sponsor
Kernel
Study ID
NCT06002100
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • fNIRS measurement — OTHER
    Kernel Flow2 measurements.

Study Details

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.

Key Dates

Start date
Aug 14, 2023
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
540 participants (estimated)

Arms

  • Arm: Ketamine
    Adult participants starting ketamine treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).
  • Arm: SPRAVATO
    Adult participants starting SPRAVATO treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).
  • Arm: TMS
    Adult participants starting TMS treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).
  • Arm: Antidepressants
    Adult participants starting antidepressant treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment and short-term efficacy visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration).

Primary Outcome Measure

Brain hemodynamic activity with TD-fNIRS [ Time Frame: Approximately 30 minutes during each study visit ]

Locations (10)

FacilityCityStateZIPSite coordinators
BrainHealth SolutionsCosta MesaCalifornia92626-
Kadima Neuropsychiatry InstituteLa JollaCalifornia92037-
Kaizen Brain Center, LLCLa JollaCalifornia92037-
Bespoke TreatmentLos AngelesCalifornia90012-
Bespoke TreatmentLos AngelesCalifornia90025-
UCLA TMSLos AngelesCalifornia90024-
Acacia ClinicsSunnyvaleCalifornia94087-
Metro Psychiatry Inc.ColumbusOhio43215-
Seattle Neuropsychiatric Treatment CenterBellevueWashington98004-
Seattle Neuropsychiatric Treatment CenterSeattleWashington98104-

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