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Enrolling by Invitation

NCT Number: NCT06002100

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.

Enrolling by Invitation

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BrainHealth Solutions, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

  • 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)

Treatment and study plan

fNIRS measurement

Other

Kernel Flow2 measurements.

Primary outcomes

  1. 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.

  2. 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.

  3. Physiological features with TD-fNIRS

    Time frame: Approximately 30 minutes during each study visit

    This includes cardiac measures, such as heart rate (HR).

  4. Physiological features with TD-fNIRS

    Time frame: Approximately 30 minutes during each study visit

    This includes cardiac measures, such as heart rate variability (HRV).

Secondary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: At baseline and closeout, up to 3 months

    Clinician-rated measure of depressive severity.

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: From baseline to closeout, up to 3 months

    9-item self-report that has been validated as a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.

  3. General Anxiety Disorder (GAD-7)

    Time frame: At baseline and closeout, up to 3 months

    7-item self-report measure used to assess participant anxiety.

  4. Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: At baseline and closeout, up to 3 months

    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.

  5. World Health Organization Quality of Life (WHOQOL-BREF)

    Time frame: At baseline and closeout, up to 3 months

    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.

  6. Revised Mystical Experience Questionnaire (RMEQ)

    Time frame: Visit 2, within approximately 7 days of baseline

    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.

Sponsors and collaborators

Lead sponsor

Kernel

Industry

Registry information

Official study title

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

Acronym: PREDICT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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