DepressionPREDICTNCT06002100
Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
An observational study of Depression and Major Depressive Disorder, run by Kernel at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- fNIRS measurement
- How many people
- 540 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Aug 2023to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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:
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- 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)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, 98004
Metro Psychiatry Inc.
Columbus, Ohio, 43215
BrainHealth Solutions
Costa Mesa, California, 92626
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
Kaizen Brain Center, LLC
La Jolla, California, 92037
Bespoke Treatment
Los Angeles, California, 90012
UCLA TMS
Los Angeles, California, 90024
Bespoke Treatment
Los Angeles, California, 90025
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
Acacia Clinics
Sunnyvale, California, 94087
About this study
Official title: PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
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.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- fNIRS measurement
- Keywords
- functional Near Infrared Spectroscopy (fNIRS), Ketamine, SPRAVATO, TMS, Antidepressants
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRS measurementOther
Kernel Flow2 measurements.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: fNIRS measurement | |
| 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). Receives: Other: fNIRS measurement | |
| 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). Receives: Other: fNIRS measurement | |
| 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). Receives: Other: fNIRS measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 30 minutes during each study visit
Physiological features with TD-fNIRS
This includes cardiac measures, such as heart rate (HR).
Measured: Approximately 30 minutes during each study visit
Physiological features with TD-fNIRS
This includes cardiac measures, such as heart rate variability (HRV).
Measured: Approximately 30 minutes during each study visit
Secondary outcomes (6)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Clinician-rated measure of depressive severity.
Measured: At baseline and closeout, up to 3 months
Patient Health Questionnaire (PHQ-9)
9-item self-report that has been validated as a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.
Measured: From baseline to closeout, up to 3 months
General Anxiety Disorder (GAD-7)
7-item self-report measure used to assess participant anxiety.
Measured: At baseline and closeout, up to 3 months
Snaith-Hamilton Pleasure Scale (SHAPS)
14-item self-administered questionnaire measuring anhedonia (inability to feel pleasure) through four domains of pleasure response: interest/pastimes, social interaction, sensory experience, and food/drink.
Measured: At baseline and closeout, up to 3 months
World Health Organization Quality of Life (WHOQOL-BREF)
26-item self-report which aims to assess an individual's quality of life. The scale was developed with a cross-cultural approach and covers domains including physical, psychological, social relationships, and environment.
Measured: At baseline and closeout, up to 3 months
Revised Mystical Experience Questionnaire (RMEQ)
30-item self-report which provides scale scores for four domains: mystical experience, positive mood, transcendence of time and space, and ineffability. Ketamine and SPRAVATO cohorts only.
Measured: Visit 2, within approximately 7 days of baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start14 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kernel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Perdue, PhD, Principal investigator, Kernel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002100
- Sponsor's protocol ID
- KER2023-2-PREDICT
- Acronym
- PREDICT
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
- ClinicalTrials.gov ID
- NCT06002100
- Acronym / sponsor ID
- PREDICT / KER2023-2-PREDICT
- Conditions
- Depression, Major Depressive Disorder
- Keywords
- functional Near Infrared Spectroscopy (fNIRS), Ketamine, SPRAVATO, TMS, Antidepressants
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- KernelIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Aug 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ketamine | – | Other: fNIRS measurementAdult 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 | – | Other: fNIRS measurementAdult 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 | – | Other: fNIRS measurementAdult 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 | – | Other: fNIRS measurementAdult 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (36 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| fNIRS measurementKernel Flow2 measurements. | Other | Antidepressants, Ketamine, SPRAVATO, TMS |
Primary outcome
Brain hemodynamic activity with TD-fNIRS
Time frame: Approximately 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-fNIRS
Time frame: Approximately 30 minutes during each study visit
This measures how much light is absorbed at different points on the head.
Physiological features with TD-fNIRS
Time frame: Approximately 30 minutes during each study visit
This includes cardiac measures, such as heart rate (HR).
Physiological features with TD-fNIRS
Time frame: Approximately 30 minutes during each study visit
This includes cardiac measures, such as heart rate variability (HRV).
6 secondary outcomes
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: At baseline and closeout, up to 3 months
Patient Health Questionnaire (PHQ-9)
Time frame: From baseline to closeout, up to 3 months
General Anxiety Disorder (GAD-7)
Time frame: At baseline and closeout, up to 3 months
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: At baseline and closeout, up to 3 months
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: At baseline and closeout, up to 3 months
Revised Mystical Experience Questionnaire (RMEQ)
Time frame: Visit 2, within approximately 7 days of baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Katherine Perdue, PhD principal investigator
Kernel
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Major Depressive Disorder, run by Kernel at 10 sites 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 36 inclusion and 19 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: enrolling by invitation, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Brain hemodynamic activity with TD-fNIRS (time frame: Approximately 30 minutes during each study visit). The study lists 4 primary outcomes in all. 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 12 Dec 2025.