Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
PREDICT
PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
1 other identifier
observational
540
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2023
CompletedStudy Start
First participant enrolled
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
December 12, 2025
December 1, 2025
3 years
August 11, 2023
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Brain hemodynamic activity with TD-fNIRS
This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.
Approximately 30 minutes during each study visit
Optical properties of the brain with TD-fNIRS
This measures how much light is absorbed at different points on the head.
Approximately 30 minutes during each study visit
Physiological features with TD-fNIRS
This includes cardiac measures, such as heart rate (HR).
Approximately 30 minutes during each study visit
Physiological features with TD-fNIRS
This includes cardiac measures, such as heart rate variability (HRV).
Approximately 30 minutes during each study visit
Secondary Outcomes (6)
Montgomery-Ă…sberg Depression Rating Scale (MADRS)
At baseline and closeout, up to 3 months
Patient Health Questionnaire (PHQ-9)
From baseline to closeout, up to 3 months
General Anxiety Disorder (GAD-7)
At baseline and closeout, up to 3 months
Snaith-Hamilton Pleasure Scale (SHAPS)
At baseline and closeout, up to 3 months
World Health Organization Quality of Life (WHOQOL-BREF)
At baseline and closeout, up to 3 months
- +1 more secondary outcomes
Study Arms (4)
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).
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).
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).
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).
Interventions
Eligibility Criteria
Adult participants seeking treatment for depression at a participating clinic/study site. Separate cohorts of participants will be enrolled depending on the treatment they have been prescribed. 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.
You may qualify if:
- 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
- +21 more criteria
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kernellead
Study Sites (10)
BrainHealth Solutions
Costa Mesa, California, 92626, United States
Kadima Neuropsychiatry Institute
La Jolla, California, 92037, United States
Kaizen Brain Center, LLC
La Jolla, California, 92037, United States
Bespoke Treatment
Los Angeles, California, 90012, United States
UCLA TMS
Los Angeles, California, 90024, United States
Bespoke Treatment
Los Angeles, California, 90025, United States
Acacia Clinics
Sunnyvale, California, 94087, United States
Metro Psychiatry Inc.
Columbus, Ohio, 43215, United States
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, 98004, United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Perdue, PhD
Kernel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2023
First Posted
August 21, 2023
Study Start
August 14, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
December 12, 2025
Record last verified: 2025-12